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

Model Number 09-09SG-0

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Discomfort (2330)

Event Type  Injury  

Event Description

A user facility nurse reported via fax that patient complained of pain and discomfort and leaking blood from the bain needles sites during treatment and excessive bleeding post treatment.(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 15G X L, FIXED
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): BAIN MEDICAL
• MDR Report Key: 17528637
• MDR Text Key: 321054649
• Report Number: MW5135567
• 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