MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NEEDLE AUTOSHIELD DUO 30GX5MM

Catalog Number	329505
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that a pen needle autoshield duo 30gx5mm broke off during use.The following information was provided by the initial reporter: "it was reported that insulin pen was unable to prime, dial was stuck.When pen needle was removed the needle became detached and remains stuck into the rubber portion of the insulin cartridge.Verbatim: autoshield attached to insulin pen.Unable to prime.Able to dial in amt of insulin but unable to discard as dial seemed to be stuck.When autoshield was removed it was noted that the needle became detached and remains stuck into the rubber portion of the insulin cartridge.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, d.10 returned to manufacturer on: 2020-07-28 h.6.Investigation summary customer returned one (1) used 30gx5mm bd autoshield duo pen needle from lot 9105646.Consumer reported that insulin pen was unable to prime, dial was stuck; when pen needle was removed the needle became detached and remains stuck into the rubber portion of the insulin cartridge.The returned pen needle was examined, and it was observed that the non-patient (npe) cannula was broken.No evidence of manufacturing defect was observed.The broken npe cannula would be the cause for no flow through the pen needle, hence, the user would think the pen needle was clogged / unable to operate (dial stuck on pen injector), as reported.Since the pen needle was returned after use, and no manufacturing defects were observed, the probable cause of the broken npe cannula is user error when attaching the pen needle to a pen injector.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 as per the applicable operations and met qc specifications.Bd was able to confirm the customer¿s indicated failure (broken npe cannula).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.See h.10.
Event or Problem Description
It was reported that a pen needle autoshield duo 30gx5mm broke off during use.The following information was provided by the initial reporter: "it was reported that insulin pen was unable to prime, dial was stuck.When pen needle was removed the needle became detached and remains stuck into the rubber portion of the insulin cartridge.Verbatim: autoshield attached to insulin pen.Unable to prime.Able to dial in amt of insulin but unable to discard as dial seemed to be stuck.When autoshield was removed it was noted that the needle became detached and remains stuck into the rubber portion of the insulin cartridge.".

• Brand Name: PEN NEEDLE AUTOSHIELD DUO 30GX5MM
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10273444
• Report Number: 9616656-2020-00669
• Device Sequence Number: 3854174
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 329505
• Device Lot Number: 9105646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other