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

Catalog Number 306572

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no: 306572 batch no: 8330636.It was reported that before use of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% there was a piece of plastic on the tip of the syringe.The following information was provided by the initial reporter: while visiting (b)(6) hospital for an in service i was approached with a sample of xs posiflush 10ml indicating that there was a visible piece of plastic on the tip of the syringe, so she capped it with a blue cap to ensure the plastic stayed intact for investigation.This has happened on multiple occasions that i was not made aware of until april 5th, 2019.

Event Description

Material no: 306572 batch no: 8330636 it was reported that before use of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% there was a piece of plastic on the tip of the syringe.The following information was provided by the initial reporter: while visiting qeh hospital for an in service i was approached with a sample of xs posiflush 10ml indicating that there was a visible piece of plastic on the tip of the syringe so she capped it with a blue cap to ensure the plastic stayed intact for investigation.This has happened on multiple occasions that i was not made aware of until (b)(6) 2019.

Manufacturer Narrative

Investigation: dhr was reviewed, the non-conformances were reviewed for this batch, and there was no record of any non-conformances associated with this issue.There was no sample received however, the photo confirmed barrel luer tip flash.The root cause may be related to moulding pin wear and inspection and detection methodology inadequacy on the moulding machine.Capa#733763 was initiated.

• Brand Name: BD POSIFLUSH¿ XS 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: 8552748
• MDR Text Key: 145639699
• Report Number: 9616657-2019-00198
• 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: 05/21/2019

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: 10/31/2021
• Device Catalogue Number: 306572
• Device Lot Number: 8330636
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other