FDA Adverse Event
Malfunction
Summary report: N
CLICKFINE 32GX4MM DONGBAO 7ER
MDR report key: 21172436
·
Received January 16, 2025
Report
- Report Number
- 3002806818-2025-00002
- Event Type
- Malfunction
- Date Received
- January 16, 2025
- Date of Event
- November 20, 2024
- Report Date
- January 16, 2025
- Manufacturer
- YPSOMED AG
- Product Code
- FMI
- PMA / PMN Number
- K171984
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 117
Narratives
Additional Manufacturer Narrative · 0
DURING AN INSULIN INJECTION BY A NURSE, THE NEEDLE WAS FOUND TO BE BLOCKED PREVENTING INJECTION AND LEADING TO PAIN FOR THE PATIENT. REVIEW OF MANUFACTURING PROCESSES AND RECORDS SHOW NO DEVIATIONS FOR THE MAIN BATCH 221649. SILICONIZATION OF THE FRONT AND BACK END HAS PERMEABILITY CHECKED 100% THROUGH AIR FLOW MEASUREMENTS OF THE FLOW STREAM. NOTHING WAS DETECTED IN-PROCESS REGARDING BLOCKAGE OR NARROWING OF THE PATH DURING THE ASSEMBLY PROCESS. NO DEVICE PROBLEM FOUND.
Description of Event or Problem · 0
DURING AN INSULIN INJECTION BY A NURSE, THE NEEDLE WAS FOUND TO BE BLOCKED PREVENTING INJECTION AND LEADING TO PAIN FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1953021 | CLICKFINE 32GX4MM DONGBAO 7ER | PEN NEEDLE | FMI | CLICKFINE 32GX4MM DONGBAO 7ER | 221649-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |