FDA Adverse Event
Malfunction
Summary report: N
JELCO
MDR report key: 13471662
·
Received February 7, 2022
Report
- Report Number
- 3012307300-2022-02777
- Event Type
- Malfunction
- Date Received
- February 7, 2022
- Report Date
- February 7, 2022
- Manufacturer
- NULL
- Product Code
- NQJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS TESTED FOR FORCE TO ADVANCE AND FORCE TO LOCK WITH NO NONCOMFORMITIES FOUND. THE REPORTED EVENT COULD NOT BE CONFIRMED AS A MANUFACTURING RELATED NONCONFORMANCE. THERE WAS NO FAULT FOUND WITH THE DEVICE.
Additional Manufacturer Narrative · 0
DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS TESTED FOR FORCE TO ADVANCE AND FORCE TO LOCK WITH NO NONCOMFORMITIES FOUND. THE REPORTED EVENT COULD NOT BE CONFIRMED AS A MANUFACTURING RELATED NONCONFORMANCE. THERE WAS NO FAULT FOUND WITH THE DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE NEEDLE WAS BLUNT WHICH MAKES IT HARD TO PIERCE SKIN WHEN INSERTING.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE NEEDLE WAS BLUNT WHICH MAKES IT HARD TO PIERCE SKIN WHEN INSERTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1212764 | JELCO | CATHETER, HEMODIALYSIS | NQJ | 4121810 | 4121810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |