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

Lot Number 032359

Device Problem Difficult to Flush (1251)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

I put an iv in the patient's arm and went to flush it with a 10 ml 0.9% sodium chloride injection.I was able to flush it fine until it got about 5 ml left in the flush, then it would not flush.I could pull blood back into the tubing and continue to flush the syringe up until it got to the 5 ml, then it would not flush any more.I placed a different flush onto the tubing and it flushed through just fine.When the "problem" flush was not attached to anything any longer i attempted to flush it again; once again it would not move past the 5 ml mark.I could pull it back, but once again could not push it past the 5 ml mark.Then once again this happened shortly afterward.A different flush was used again when another nurse on the floor was putting an iv in.Once again, it would not flush past the 4 ml point of the syringe.Another flush gotten, and it worked just fine.When this "problem" flush was taken off the iv line, once again tried to push the fluid through the flush.Could not push it past the 4 ml point of the flush, could pull the fluid back in the syringe but not flush it through past the 4 ml point of syringe.Did not save the first flush that it happened to; but the second flush that it happened to was in lot: 032359.

• Brand Name: 0.9% SODIUM CHLORIDE INJECTION POSIFLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 11514757
• MDR Text Key: 241026875
• Report Number: MW5100076
• Device Sequence Number: 2
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 032359
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1