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

Catalog Number	UNKNOWN
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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.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 was broken.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown it was reported that the non patient end is broken.Verbatim: rear cannula end is broken + gets stuck.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) loose bd pen needle without a tear drop label attached, and a broken non-patient end cannula.Consumer reported rear cannula end is broken + gets stuck.The returned pen needle was examined and exhibited a broken non-patient end cannula, likely due to improper attachment to the pen injector by the user, thus confirming the alleged defect.Unable to perform dhr review due to unknown lot number for broken npe.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 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 broken when fitted to the pen.
Event or Problem Description
It was reported that unspecified bd¿ pen needle was broken.The following information was provided by the initial reporter: material no.Unknown, batch no.Unknown.It was reported that the non patient end is broken.Verbatim: rear cannula end is broken + 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: 8603670
• Report Number: 2243072-2019-00907
• Device Sequence Number: 11336336
• 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): 05/21/2019

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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