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

Catalog Number 306572

Device Problem Short Fill (1575)

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

Event Date 09/24/2018

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 a bd posiflush¿ xs pre-filled flush syringe was only filled one-quarter of the way when it was received.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

Investigation summary: one sample unit belonging to lot number 7206988 was received for evaluation by our quality engineer team.A device history record review for the reported lot number did not reveal any anomalies during production that could have contributed to this incident.Through visual inspection of the sample, the syringe was observed to be under-filled.It has been determined that the incorrect fill was a result of a jam or crash within the assembly line.This failure within the assembly process resulted in the barrel receiving an incorrect volume of saline.Based on an evaluation of the frequency and severity of this defect, further action has not been determined necessary at this time.Complaints received for this device and issue will continue to be monitored by our quality team for emerging trends.

Event Description

It was reported that a bd posiflush¿ xs pre-filled flush syringe was only filled one-quarter of the way when it was received.There was no report of exposure, serious injury, or medical intervention.

• 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: 8030275
• MDR Text Key: 126083880
• Report Number: 9616657-2018-00048
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 306572
• Device Lot Number: 7206988
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other