MAUDE Adverse Event Report: BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD., NO. BAIN FISTULA NEEDLE 15GX1, FIXED; NEEDLE, FISTULA

Model Number 09-09SG-0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  Injury  

Event Description

A user facility clinical manager reported to fresenius customer service via fax that the bain fistula needles hurt going in and the patients have been bleeding during 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 15GX1, FIXED
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD., NO.
• MDR Report Key: 17531238
• MDR Text Key: 321137024
• Report Number: MW5138152
• 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: 06/18/2020

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
• Device Lot Number: 201902011781
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1