MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ NS FILLED SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306546

Device Problem Difficult to Advance (2920)

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

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

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 posiflush¿ ns filled syringe there was an issue with plunger movement difficult.There was no report of injury or medical intervention.

Event Description

It was reported with the use of the bd posiflush ns filled syringe there was an issue with plunger movement difficult.There was no report of injury or medical intervention.

Manufacturer Narrative

A device history record review did not reveal any documented quality issues during the production of lot number 8206908 that could have contributed to the reported incident.As a sample was unavailable for return, a thorough sample investigation could not be completed and the defect could not be substantiated.Based on the limited investigation, an exact cause for the reported incident could not be determined.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

• Brand Name: BD POSIFLUSH¿ NS FILLED SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8126465
• MDR Text Key: 129478914
• Report Number: 9616657-2018-00061
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

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: 06/30/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8206908
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other