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

Lot Number 0293282

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Infusion nurse attempted to flush line with 0.9% sodium chloride injection (lot: 0293282).After 5 ml infused from the syringe, the syringe locked up and couldn't be pushed any further.

• 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: 12421639
• MDR Text Key: 270218658
• Report Number: MW5103720
• Device Sequence Number: 1
• Product Code: NGT
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2021
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 56