FDA Adverse Event
Malfunction
Summary report: N
CLICKFINE 32GX4MM DONGBAO 7ER
MDR report key: 20914207
·
Received December 12, 2024
Report
- Report Number
- 3002806818-2024-00029
- Event Type
- Malfunction
- Date Received
- December 12, 2024
- Date of Event
- October 15, 2024
- Report Date
- December 12, 2024
- Manufacturer
- YPSOMED AG
- Product Code
- FMI
- PMA / PMN Number
- K171984
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT FELT PAIN WHEN COMPLETING AN INSULIN INJECTION. THE PATIENT REPORTED THAT THE NEEDLE WAS BENT. REVIEW OF MANUFACTURING SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS, INCLUDING IN-PROCESS CONTROL FOR PENETRATION FORCE. IN-PROCESS CONTROL FOR ANGLE AND THE NEEDLE TIP TO THE CANNULA IS 100% COMPLETED BEFORE THE INNER PROTECTIVE CAP IS FITTED. NO DEVICE PROBLEM COULD BE FOUND.
Description of Event or Problem · 0
THE PATIENT FELT PAIN WHEN COMPLETING AN INSULIN INJECTION. THE PATIENT REPORTED THAT THE NEEDLE WAS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2146141 | CLICKFINE 32GX4MM DONGBAO 7ER | PEN NEEDLE | FMI | YPSOMED AG | CLICKFINE 32GX4MM DONGBAO 7ER | 231190-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |