MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: 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 the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% luer-lock connector was found broken before use.The following information was provided by the initial reporter: "broken luer-lok connector".

Manufacturer Narrative

Investigation: one sample was received.The plunger rod- rubber stopper is all the way down to the 1.5 ml mark on the scale.It has residues of a drug/ medication or dried blood in the bottom part of the syringe and the luer.The barrel label confirms the lot# 8360801.The luer shows a deformation on the top part where the threads start.The photos show the syringe with the luer damaged/ deformed and the barrel label.It is possible that the syringe was damaged at the fill machine during production.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% luer-lock connector was found broken before use.The following information was provided by the initial reporter: "broken luer-lok connector".

• Brand Name: BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8730840
• MDR Text Key: 149229402
• Report Number: 1911916-2019-00624
• 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: 07/03/2019

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: 12/31/2021
• Device Catalogue Number: 306575
• Device Lot Number: 8360801
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other