FDA Adverse Event
Malfunction
Summary report: N
BAIN FISTULA NEEDLE 1 5GX I, FIXED
MDR report key: 17528781
·
Received August 12, 2023
Report
- Report Number
- MW5135710
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- December 1, 2020
- Manufacturer
- BAIN MEDICAL EQUIPMENT
- Product Code
- FIE
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A DIALYSIS PATIENT REPORTED TO CLINICAL SERVICE THAT IT TOOK ABOUT 3 NEEDLES TO GET HER STARTED. THE TECHNICIAN TRIED MOVING THE NEEDLE FURTHER IN AND EVEN FURTHER OUT UP TO THE POINT WHERE THE PATIENT STARTED BLEEDING. IT TOOK 3 NEEDLES TO GET IT RIGHT. SHE EXPLAINED HOW IT CAN CAUSE A SCAB, THE SCAB TAKES A WHILE TO HEAL, AND CAN EVENTUALLY LEAD TO HER HAVING TO GET A NEW FISTULA. SHE SAID THE NEEDLES CAUSE BIGGER HOLES AND TAKE A LONGER TIME TO HEAL. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 564197 | BAIN FISTULA NEEDLE 1 5GX I, FIXED | NEEDLE, FISTULA | FIE | BAIN MEDICAL EQUIPMENT | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |