MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE

Catalog Number	UNKNOWN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that an unspecified bd pen needle experienced a cannula that broke off or pulled out.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Rear cannula end is broken + gets stuck.
Event or Problem Description
It was reported that an unspecified bd pen needle experienced a cannula that broke off or pulled out.The following information was provided by the initial reporter: material no: unknown batch no: unknown rear cannula end is broken + gets stuck.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-01-28 h6: investigation summary customer returned one (1) used 32g x 4mm bd pen needle without a cover or tear drop label attached.Consumer reported rear cannula end gets stuck and the rear cannula end is broken.The returned pen needle was examined, and it was observed that the non-patient end (npe) cannula was broken.The broken npe cannula suggests that the consumer improperly attached the pen needle to a pen injector causing the npe cannula to get stuck, and subsequently break.No evidence of manufacturing defect was observed, therefore, the probable cause of the broken npe cannula is user error when attaching the pen needle to a pen injector.No dhr review can be carried out as lot number is unknown.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 h10.

• Brand Name: UNSPECIFIED BD PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11189557
• Report Number: 2243072-2021-00135
• Device Sequence Number: 11645938
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1