MAUDE Adverse Event Report: BAIN MEDICAL BAIN FISTULA NEEDLE 16GX1, FIXED 25MM; NEEDLE, FISTULA

Model Number BAIN-A.V.F009SG

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A user facility clinical manager reported via email about the issues of bain fistula needle.The needle lines are not clamping all the way, tubing is flimsy and leaving blood spills.The comment was made that the needles feel more flimsy; a trail of blood comes out of the needle when the safety device is engaged.Great care must be taken to ensure the needles does not come out the side of the safety device.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BAIN FISTULA NEEDLE 16GX1, FIXED 25MM
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): BAIN MEDICAL
• MDR Report Key: 17530946
• MDR Text Key: 321054881
• Report Number: MW5137862
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2020

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?: No
• Device Model Number: BAIN-A.V.F009SG
• Device Lot Number: 201902011752
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1