MAUDE Adverse Event Report: BAIN MEDICAL EQUIPMENT (GUANGZHU), NO. 10, JUNCHEN BAIN FISTULA NEEDLE 15GX1, FIXED; NEEDLE, FISTULA

Model Number 09-09SG-0

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A user facility clinical manager reported via fax that the fistula needle causes bleeding around needle sites during treatment.It was reported that 100 cc was lost from attempts to reposition and stop the bleeding.Blood was gushing from the needle site.Needle was removed and treatment ended one hour early due to patient not wanting to recannulate.(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 (GUANGZHU), NO. 10, JUNCHEN
• MDR Report Key: 17536341
• MDR Text Key: 321147953
• Report Number: MW5143229
• 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
• Device Lot Number: 201902911781
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1