MAUDE Adverse Event Report: BD 0.9% SODIUM CHLORIDE INJECTION BD POSIFLUSH 10 ML; SALINE, VASCULAR ACCESS FLUSH

Lot Number 0293282

Device Problem Difficult to Flush (1251)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

Event Type  malfunction  

Event Description

A 0.9% sodium chloride inj.Usp bd posiflush 10 ml syringe.Lot 0293282.Rn flush port-a-cath.Saline flush stopped after partial dose administered.Couldn't push forward or pull back.Prior and subsequent flushes (same lot) worked fine.

• Brand Name: 0.9% SODIUM CHLORIDE INJECTION BD POSIFLUSH 10 ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 11677713
• MDR Text Key: 245994530
• Report Number: MW5100800
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2023
• Device Lot Number: 0293282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 81