MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

Catalog Number 329605

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd autoshield¿ duo safety pen needle was leaked during use.

Manufacturer Narrative

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

Event Description

It was reported that bd autoshield¿ duo safety pen needle was leaked during use.

• Brand Name: BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8204057
• MDR Text Key: 131706901
• Report Number: 9616656-2018-00332
• Device Sequence Number: 1
• Product Code: FMF
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 329605
• Device Lot Number: 8017860
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other