FDA Adverse Event
Malfunction
Summary report: N
CLICKFINE 32GX4MM DONGBAO 7ER
MDR report key: 20854484
·
Received December 5, 2024
Report
- Report Number
- 3002806818-2024-00026
- Event Type
- Malfunction
- Date Received
- December 5, 2024
- Date of Event
- October 4, 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
- 003
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT FELT PAIN AFTER COMPLETING A GLARGINE INSULIN INJECTION AT HOME. THE NEEDLE CANNULA WAS FOUND BENT AND BLUNT. REVIEW OF MANUFACTURING SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH. IN-PROCESS ANGLE CONTROL FOR THE NEEDLE TIP IS 100% COMPLETED. NO DEVICE PROBLEM COULD BE FOUND.
Description of Event or Problem · 0
THE PATIENT FELT PAIN AFTER COMPLETING A GLARGINE INSULIN INJECTION AT HOME. THE NEEDLE CANNULA WAS FOUND BENT AND BLUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2489545 | CLICKFINE 32GX4MM DONGBAO 7ER | PEN NEEDLE | FMI | YPSOMED AG | CLICKFINE 32GX4MM DONGBAO 7ER | 231670-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |