MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD PEN NDL 31G 5MM; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320882
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: n/a.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 the tear drop label is missing thus affecting sterility with a bd pen ndl 31g 5mm.This occurred on 5 separate occasions, however, the date/time information is unknown.The following information was provided by the initial reporter: it was reported that the tear drop label of the pen needle is missing.
Event or Problem Description
It was reported that the tear drop label is missing thus affecting sterility with a bd pen ndl 31g 5mm.This occurred on 5 separate occasions, however, the date/time information is unknown.The following information was provided by the initial reporter: it was reported that the tear drop label of the pen needle is missing.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.

• Brand Name: BD PEN NDL 31G 5MM
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9008521
• Report Number: 9616656-2019-00860
• Device Sequence Number: 2183967
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 320882
• Device Lot Number: 2283312
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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