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

Model Number BAIN-A.V.F-009SG

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A user facility clinical manager reported via email bain-a.V.(b)(4) on which the patient alarmed multiple times on two separate occasions; this file documents the second instance.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 device 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: 17527664
• MDR Text Key: 321054779
• Report Number: MW5134596
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: BAIN-A.V.F-009SG
• Device Lot Number: 201902011752
• Patient Sequence Number: 1