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

Catalog Number 329605

Device Problems Mechanical Problem (1384); Protective Measures Problem (3015)

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

Event Date 01/11/2019

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 with the use of the bd autoshield¿ duo safety pen needle there was an issue with the protective cover not flicking back over despite being fully back for the injection.

Event Description

It was reported with the use of the bd autoshield¿ duo safety pen needle there was an issue with the protective cover not flicking back over despite being fully back for the injection.

Manufacturer Narrative

Investigation summary: no samples or photos were returned for analysis.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Root cause is undetermined.

• Brand Name: BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8281891
• MDR Text Key: 134327539
• Report Number: 9616656-2019-00115
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 329605
• Device Lot Number: 8229804
• Initial Date Manufacturer Received: 01/12/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/12/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other