MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE FLUSH

Catalog Number 306572

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 11/19/2018

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 that two bd posiflush¿ xs pre-filled flush syringes nacl 0.9%, "were strangely 'hard' after injecting half the content, so much that we feared there was obstruction to the port.".

Manufacturer Narrative

Investigation summary: batch code 8185572 for material number 306572 was provided for evaluation by our quality engineer.A device history record review did not reveal any detected defects during the production of batch code 8185572 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.Due to the absence of a sample the complaint could not be substantiated.

Event Description

It was reported that two bd posiflush¿ xs pre-filled flush syringes nacl 0.9%, "were strangely 'hard' after injecting half the content, so much that we feared there was obstruction to the port.".

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8170749
• MDR Text Key: 130644500
• Report Number: 9616657-2018-00072
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: 382903065721
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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: 12/07/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other