MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ SYRINGE WITH NEEDLE

Catalog Number 302151

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle cover of a bd¿ syringe with needle was not covered, creating a sterile breach.The user was injured by the exposed clean needle.There was no report of exposure or medical intervention.

Manufacturer Narrative

Investigation results: no photos or samples were returned.Root cause could not be determined.If samples are received in the future the complaint will be re-opened and re-investigated.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Reviewed syringe device history record (dhr) and no quality notification was raised for the reported batch.No formal corrective action will be needed.

• Brand Name: BD¿ SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7403477
• MDR Text Key: 104871012
• Report Number: 8041187-2018-00107
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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: 302151
• Device Lot Number: 7205480
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other