MAUDE Adverse Event Report: UNKNOWN BAIN FISTULA NEEDLE 15GX1, FIXED; NEEDLE, FISTULA

Device Problems Fluid/Blood Leak (1250); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2021

Event Type  malfunction  

Event Description

A user facility hemodialysis technician reported via fax: the caps at end of the needle line comes off after sticking access - blood then leaks down blood lines after cap comes off causing blood leak.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BAIN FISTULA NEEDLE 15GX1, FIXED
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17525773
• MDR Text Key: 321375228
• Report Number: MW5132714
• 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: 08/20/2021

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
• Patient Sequence Number: 1