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

Catalog Number	329505
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of pen needle autoshield duo 30gx5mm experienced safety shield failure which was noted during use.The following information was provided by the initial reporter: material no: 329505, batch no: 8241576.Verbatim: when administering insulin injection, the safety did not fully engage and bent over.No difficulty with injection that would have bent the needle on insertion or removal.
Additional Manufacturer Narrative
H.6.Investigation: customer returned one (1) used 30g x 5mm, bd autoshield duo pen needle.Consumer reported when administering insulin injection, the safety did not fully engage and bent over.The returned sample was examined, and it was observed that the non-patient end (npe) cannula was bent, thus preventing the npe cannula safety-shield mechanism from properly activating.It was also observed that the patient end (pe) cannula safety-shield mechanism had properly activated.Since the sample was returned after use, and no manufacturing defects were observed, the probable cause of the bent 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 per the applicable operations and met qc specifications.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 : see h.10.
Event or Problem Description
It was reported that an unspecified number of pen needle autoshield duo 30gx5mm experienced safety shield failure which was noted during use.The following information was provided by the initial reporter: material no: 329505 batch no: 8241576 verbatim: when administering insulin injection, the safety did not fully engage and bent over.No difficulty with injection that would have bent the needle on insertion or removal.

• 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: 8875371
• Report Number: 9616656-2019-00724
• Device Sequence Number: 2499353
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• 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): 08/28/2019

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 329505
• Device Lot Number: 8241576
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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