MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE

Catalog Number	UNKNOWN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that unspecified bd¿ pen needle rear cannula broke.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that needle(s) bent, rear cannula end is broken and gets stuck.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) open 4mm, 32g pen needle without the tear drop label, inner shield, or outer cover.Customer states that the needle was bent.The returned pen needle was examined and exhibited a bent patient and non patient end of the cannula.Unable to perform dhr check due to an unknown lot number for needle bent & needle broken npe.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 unspecified bd¿ pen needle rear cannula broke.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that needle(s) bent, rear cannula end is broken and gets stuck.

• 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: 9849159
• Report Number: 2243072-2020-00423
• Device Sequence Number: 2377940
• 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): 03/25/2020

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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