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

Catalog Number 329605

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd autoshield¿ duo safety pen needle did not fully retract during use and medication remained in the needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "secure needle not fully retracted and treatment remained in the needle.".

Event Description

It was reported that the bd autoshield¿ duo safety pen needle did not fully retract during use and medication remained in the needle.The following information was provided by the initial reporter, translated from french to english: "secure needle not fully retracted and treatment remained in the needle.".

Manufacturer Narrative

H.6.Investigation: one open 30g x 5mm safety pen needle sample was returned from lot.No.9175940, cat.No.329605.Visual examination of the returned sample was carried out it was observed that sample was activated 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.No issues were observed with the returned sample therefore no root cause be identified.H3 other text : see h.10.

• 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: 9521281
• MDR Text Key: 194124097
• Report Number: 9616656-2019-01269
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 329605
• Device Lot Number: 9175940
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other