MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; PRE-FILLED SYRINGE

Catalog Number 306575

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2019

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 prior to use the plunger was not working with a 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: the nursing staff reported issue with the plunger not moving.

Event Description

It was reported that prior to use the plunger was not working with a 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: the nursing staff reported issue with the plunger not moving.

Manufacturer Narrative

H.6.Investigation summary: bd was able to verify the reported complaint with the returned samples.There was a record of an intermittent issue with the hosing which was resolved at time of issue.Product associated with the defect was held for inspection, and the affected material was scrapped.It is possible that the issue may have been intermittent prior to detection and there may have been a limited occurrence outside the contained material.Dhr: the non-conformances were reviewed for this batch, and there was a record of non-conformance associated with this batch.H3 other text : see section h.10.

• Brand Name: 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PRE-FILLED SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8768064
• MDR Text Key: 160231166
• Report Number: 9616657-2019-00250
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9042537
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other