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

Model Number 09-09SG-0

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A user facility clinical manager reported via fax that the bain fistula needles are dangerous when pulling the needle and engaging safety guards.Needles are exposed at end and cannot engage to cover the needle completely resulting in bleeding from the access site.(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 15GX1, FIXED
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): BAIN
• MDR Report Key: 17523738
• MDR Text Key: 321054542
• Report Number: MW5130686
• 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: 06/26/2020

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: 09-09SG-0
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1