MAUDE Adverse Event Report: UNKNOWN BAIN FISTULA NEEDLE 15 G X L, FIXED; NEEDLE, FISTULA

Model Number 09-09SG-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A user facility nurse reported via fax that the blood was leaking from both bain needle sites during treatment and prolonged bleeding after treatment.(b)(6), (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 15 G X L, FIXED
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533181
• MDR Text Key: 321165556
• Report Number: MW5140085
• 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: 12/01/2020

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: 09-09SG-0
• Device Lot Number: ,202002010048
• Patient Sequence Number: 1