MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE; SALINE FLUSH

Catalog Number 306572

Device Problem Difficult to Advance (2920)

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

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd posiflush¿ xs pre-filled flush syringe plunger is difficult to move.No serious injury or medical intervention was reported.

Event Description

It was reported that bd posiflush¿ xs pre-filled flush syringe plunger is difficult to move.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: batch number 8185572 was provided for evaluation by our quality engineer team.A device history record review was performed for the provided lot number and it did not reveal any quality issues during the production process that could have contributed to the reported incident.As neither a physical sample nor a picture sample was available for return, a thorough sample investigation could not be completed.Investigation conclusion: based on the limited investigation results, the complaint could not be substantiated and a cause for the reported incident could not be determined.Rationale: complaints received for this device and defect will be closely monitored by our quality team for signs of emerging trends.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8219765
• MDR Text Key: 132214319
• Report Number: 9616657-2018-00079
• Device Sequence Number: 1
• Product Code: NGT
• 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: 01/31/2019

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: 06/30/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8185572
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other