Letter regarding faulty BD syringes

18th June 2004

Dear Mr McGowan,

RE: Becton Dickenson 1ml Microfine Insulin Syringes

You will perhaps already know that a meeting of the National Needle Exchange Forum was held in London on the 1st of April 2004. The agenda included a discussion of the problems which have been experienced by needle exchanges with the above product since the latter part of 2003. More than one hundred members of the Forum from all parts of the country attended. Following the meeting, a number of members have written to us giving details of their own experiences.

Recently I received a copy of the letter in which you acknowledge “less than optimal needle point quality” as regards three specific lot numbers. I am now writing on behalf of the Forum in order to let you know the views which our members have expressed. I enclose a summary of the comments we have received. These make clear that the reliability of injecting equipment is a key issue for our members, when seeking to gain the trust of drug injectors and to promote safer injecting behaviour.

We are, of course, pleased to hear that you have now examined your manufacturing process with a view to improving quality control. However, we feel disappointed that it has taken several months to receive an acknowledgement of the reality of the problem. Members who spoke at the meeting recounted similar experiences of making approaches to your company, which they consider were not taken as seriously as they deserved to be. It was clear from the meeting that the same problems were being experienced by different agencies, but people were told that their complaint was an “isolated incident”. Our colleague Dr. Elliot Imbert of Apothicom in France was also present at the meeting, and reported that he had experienced the same difficulties.

Your product remains the brand leader in the field. We are therefore surprised that Becton Dickenson did not respond more quickly to protect the reputation of your company and product. We would like to be assured that your response would be more rapid if a similar problem should emerge in future. Needle exchanges account for a large part of the market for injecting equipment. As your insulin syringes currently cost approximately two pence each more than rival products, it seems reasonable for us to expect a higher level of quality and customer care from your company.

Yours faithfully,
Alan Neill
Member of NNEF Planning Group

c.c. Ralph Hilberath, BD France
c.c. Kim Jones, BD Oxford

Written comments were received from several agencies throughout England, as well as those expressed at the Forum Meeting held in London on 1st April 2004. The following extracts include comments from harm reduction agencies in Lincolnshire, Manchester, Sheffield, the Midlands, London, and Devon.

• “During January we were getting complaints from our needle exchanges about 1ml BD needles being either blunt or barbed, or becoming detached from the barrels.”
• “Our needle exchanges cannot be seen to be issuing faulty needles as our work mainly advocates safer injecting techniques…Clients may then be at risk of developing infected injecting sites due to faulty equipment.”
• “It could drive clients to go back to sharing injecting equipment, which could then lead to an increase in blood-borne viruses.”
• “Initially the company were unhelpful saying that no-one else had complained. After our initial package went to Ireland for analysis we heard nothing.”
• “Clients were complaining of blunt, barbed and leaking needles, sometimes there being two needles coming from a barrel.”
• “We saw the evidence from two clients who brought them in to show us of the needle becoming detached from the barrel.”
• “There seems to have been a known problem for several months ….. and these batches have not been officially recalled.”
• “Providing faulty goods will undo the hard work and effort we put in to gain our clients’ trust.”
• “Provision of sub-standard goods will not encourage attendance for clean equipment.”
• “I should also like to share with you some of their comments: Are they seconds? Have these needles been recycled?”
• “The problems that were reported were as follows:
  • The needle is flimsy, not sturdy enough.
  • More than one needle on the end of the syringe.
  • The needle is bent.
  • The needle is already barbed (before being used).
  • It won’t draw up.
  • The plunger bounced.
  • The needle became detached from the syringe.”
• “We all seem to be told that this is an isolated incident when we know this is not the case.”

1st July 2004

Subject : BD Micro-Fine+ 1ml insulin syringes

Dear Mr Neill,

Thank you for your letter dated 18th June 2004. We note the comments from the members of the forum and thank them for their views and feedback.

As mentioned in your letter, with the co-operation of a number of needle exchange agencies, we have been able to identify three lots of syringes with less than optimal needle point quality. In April we took the voluntary decision to accept the return of products from these three lots and since that date we have had 84 cases returned. We are now monitoring the situation very closely and urge the members of the forum to inform us directly of any further complaints they may receive.

We acknowledge that during the initial period BD did not respond as quickly as customers would have wished and I apologise for this delay in resolving the issue. However, we feel it is also important to point out that a more rapid and conclusive investigation of the complaints was made more difficult for a number of reasons. Firstly, in the early stages the actual number of direct complaints received by BD was relatively few, even though we were aware of a significant level of discussion between agencies and on the market in general. Secondly, the low number of samples returned to BD for analysis made it difficult to assess the frequency and extent of the potential manufacturing issue. Several agencies assisted us greatly in our investigation and we thank them for their co-operation and patience. Direct communication, supported by clear descriptions of complaints and provision of representative samples is critical in helping us to identify and resolve manufacturing issues most effectively.

It is also important to mention at this point that syringes should not be returned directly to the BD Oxford office in the regular mail without notice or indication of content. We do have in place a procedure that is worth clarification to ensure rapid and safe analysis of potential complaints:

• Telephone Gemma Bianchini (Tel 01865 781634), or Kim Jones (Tel 07818 004002) to report the complaint. We need lot number, expiry date and to know the precise quantity of products involved in the complaint.
• If further investigation is required, we will instruct DHL to deliver a sharps container directly to the needle exchange agency for collection of the relevant samples. These will be taken for analysis directly to the manufacturing plant in Ireland.
• Once the analysis of the plant is complete, we will communicate directly with the needle exchange agency and advise on the action we will take.

BD is aware that the quality of our product is an important part of the continued success of needle exchange programmes. With this in mind, we would welcome the opportunity to meet with representatives of the National Needle Exchange Forum to identify areas for improvement and development of our products.

Once again, thank you for your letter together with the comments of the members of the forum. We look forward to continued co-operation together with the joint objective of improving our products and services for the needle exchange programmes.

Yours sincerely,
Michael McGowan
Sales and Marketing Director