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 Device Difficult to Setup or Prepare (1487)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A user facility clinical manager reported via fax that they are having issues with bain fistula needles.They noted that there is increased bleeding of access site around the needle insertion areas and that the needles have larger hubs.(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: 17535871
• MDR Text Key: 321057392
• Report Number: MW5142764
• 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: 06/29/2020

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: 201902011779
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1