MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD PEN NDL 32G 4MM; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320883

Device Problem Failure to Deliver (2338)

Patient Problems Dizziness (2194); Underdose (2542)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no: 320883, batch no: 8227655.It was reported that during use of the bd pen ndl 32g 4mm the non patient end of the pen needle was missing preventing the delivery of insulin.After the user checked the pen needle on three other needles he was able to find on with the needle attached allowing him to receive the insulin.The following information was provided by the initial reporter: consumer reported, after his injection yesterday, he felt dizzy.Stated his numbers were high because he did not get his insulin.The insulin did not flow when injecting.When he removed the pen needle, the non patient end was missing.He found two more pen needles, missing non patient end prior to injection.When he pulled out a 4th pen needle, he was able to take his injection successfully.Stated it happened again today, non patient end was missing prior to injection.(could not use) he checks the non patient end now before attempting to attach to insulin pen.Stated, he's better now and did not see a doctor.

Manufacturer Narrative

H.6.Investigation: customer returned nine (9) 32g x 4mm bd pen needles from lot: 8227655.Consumer reported the following: after his injection yesterday, he felt dizzy; stated his numbers were high because he did not get his insulin; the insulin did not flow when injecting; when he removed the pen needle, the non-patient end was missing.All nine returned samples were examined, and it was observed that eight were sealed (unused), and one was opened/used.The used pen needle had a broken non-patient end (npe) cannula (see attached photo); however, no evidence of manufacturing defects were observed.The eight samples that were returned unused had no apparent issues.These eight samples were then tested for flow using a test pen injector: all eight pen needles were able to expel properly.As no manufacturing defects were observed, the probable cause of the broken npe cannula on the used sample is user error when attaching the pen needle to a pen injector.The broken npe cannula would be the cause for no flow through the pen needle, hence, the customer would think the pen needles were clogged.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (broken npe cannula).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (clog).The possible root cause for this issue is: user error.No evidence of manufacturing related issues were observed on the returned samples.It is bd¿s experience that the non-patient end breakage and bending is directly associated with the placing of the needle onto the pen device by the user.If the non-patient end of the needle is not placed centrally to the pen device, then instead of the non-patient end of the needle piercing the rubber septum of the vial, it hits hard material and can be bent/broken when fitted to the pen.H3 other text.

Event Description

Material no: 320883, batch no: 8227655.It was reported that during use of the bd pen ndl 32g 4mm the non patient end of the pen needle was missing preventing the delivery of insulin.After the user checked the pen needle on three other needles he was able to find on with the needle attached allowing him to receive the insulin.The following information was provided by the initial reporter: consumer reported, after his injection yesterday, he felt dizzy.Stated his numbers were high because he did not get his insulin.The insulin did not flow when injecting.When he removed the pen needle, the non patient end was missing.He found two more pen needles, missing non patient end prior to injection.When he pulled out a 4th pen needle, he was able to take his injection successfully.Stated it happened again today, non patient end was missing prior to injection.(could not use) he checks the non patient end now before attempting to attach to insulin pen.Stated, he's better now and did not see a doctor.

• Brand Name: BD PEN NDL 32G 4MM
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8970689
• MDR Text Key: 156910717
• Report Number: 9616656-2019-00837
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (y/n): N
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 320883
• Device Lot Number: 8227655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other