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 Information (3190)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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.

Manufacturer Narrative

Eighteen samples belonging to lot number 8192991 were received for evaluation by our quality engineer.Through visual and functional inspection of the returned samples, it was determined that the plunger movement was defective.Dhr review showed that during the production process of lot number 8192991, there was one documented non-conformance that could have contributed to this defect.During production, a damaged silicone canister was found within the silicone station, which resulted in an insufficient supply of silicone to the syringe barrels.Product associated with this non-conformance was held for inspection and all affected material should have been discarded.It is possible that a misdetection in defective product caused this incident, as the samples were not properly discarded.The damaged silicone canister has since been replaced.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported with the use of the bd posiflush ns filled syringe there was an issue with plunger movement difficult.

• 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: 8126436
• MDR Text Key: 129576631
• Report Number: 9616657-2018-00062
• 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: 12/17/2018

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: 8192991
• 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: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other