MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PN 32X4 100 PK GERMANY; PEN NEEDLES

Catalog Number 325103

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples or photos were returned for analysis.Investigation conclusion: no samples or photos were returned for analysis.A lot history review was carried out and no related non conformance were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Root cause description: no samples or photos were returned for analysis.

Event Description

It was reported that a needle break occurred during use with a pn 32x4 100 pk germany.The following information was provided by the initial reporter, "needles bent respectively broken npe.".

Event Description

It was reported that a needle break occurred during use with a pn 32x4 100 pk germany.The following information was provided by the initial reporter, "needles bent respectively broken npe.".

Manufacturer Narrative

H.6 investigation: five photos were returned from lot.No.9149882, cat.No.325103.Visual examination of the returned photos was carried out and no issues were observed.Visual examination of the returned photos was carried out and no issues were observed.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.Based on the photos returned and the fact no sample was received no further investigation can be carried out.

• Brand Name: PN 32X4 100 PK GERMANY
• Type of Device: PEN NEEDLES
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9525437
• MDR Text Key: 193915251
• Report Number: 9616656-2019-01273
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 325103
• Device Lot Number: 8149882
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other