FDA Adverse Event
Malfunction
Summary report: N
CLICKFINE 32GX4MM DONGBAO 7ER
MDR report key: 20134584
·
Received September 4, 2024
Report
- Report Number
- 3002806818-2024-00022
- Event Type
- Malfunction
- Date Received
- September 4, 2024
- Date of Event
- August 16, 2024
- Report Date
- September 4, 2024
- Manufacturer
- YPSOMED AG
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT FELT PAIN DURING A SELF-INJECTION. UPON EXAMINATION, THE NEEDLE TIP WAS OBSERVED TO HAVE A HOOK APPEARANCE. THE SYMPTOM IMPROVED WHEN THE PATIENT STOPPED USING THE NEEDLE. REVIEW OF MANUFACTURING SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH (B)(6), 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 DURING A SELF-INJECTION. UPON EXAMINATION, THE NEEDLE TIP WAS OBSERVED TO HAVE A HOOK APPEARANCE. THE SYMPTOM IMPROVED WHEN THE PATIENT STOPPED USING THE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1055435 | CLICKFINE 32GX4MM DONGBAO 7ER | PEN NEEDLE | FMF | YPSOMED AG | CLICKFINE 32GX4MM DONGBAO 7ER | 211659-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |