FDA Adverse Event
Malfunction
Summary report: N
CLICKFINE 32GX4MM DONGBAO 7ER
MDR report key: 20854645
·
Received December 5, 2024
Report
- Report Number
- 3002806818-2024-00025
- Event Type
- Malfunction
- Date Received
- December 5, 2024
- Date of Event
- September 20, 2024
- Report Date
- November 15, 2024
- Manufacturer
- YPSOMED AG
- Product Code
- FMI
- PMA / PMN Number
- K171984
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE FRONT-END CANNULA WAS OBSERVED TO BE BENT AND SCRATCHED THE PATIENT'S SKIN DURING AN INSULIN INJECTION BY A NURSE. NO INFORMATION ON LOT NUMBER WAS PROVIDED. HOWEVER, THE MANUFACTURING PROCESS WAS REVIEWED AND THE ANGLE FROM THE CANNULA IS 100% CONTROLLED BEFORE THE INNER PROTECTIVE CAP IS FITTED.
Description of Event or Problem · 0
THE FRONT-END CANNULA WAS OBSERVED TO BE BENT AND SCRATCHED THE PATIENT'S SKIN DURING AN INSULIN INJECTION BY A NURSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2114509 | CLICKFINE 32GX4MM DONGBAO 7ER | PEN NEEDLE | FMI | YPSOMED AG | CLICKFINE 32GX4MM DONGBAO 7ER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |