FDA Adverse Event
Malfunction
Summary report: N
SOL-M CATHETER TIP SYRINGE
MDR report key: 18478088
·
Received January 9, 2024
Report
- Report Number
- 3014312726-2024-00091
- Event Type
- Malfunction
- Date Received
- January 9, 2024
- Report Date
- January 9, 2024
- Manufacturer
- SOL-MILLENNIUM MEDICAL INC
- Product Code
- FMI
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CUSTOMER REPORTED: WHEN THE PACKAGING IS OPENED, THE WELD SEAM STICKS TO THE PAPER SO FIRMLY THAT THE PACKAGING TEARS. A STERILE PROCEDURE IS ALMOST IMPOSSIBLE. THE SITUATION ARISES WITH EVERY PACKAGE, SO IT IS NOT A SPECIFIC BATCH THAT IS AFFECTED, BUT FAULTY PACKAGING PRODUCTION IS MORE LIKELY TO BE THE CAUSE. PRODUCTS BECOME UNSTERILE DUE TO DEFECTIVE PACKAGING. STERILITY CANNOT BE GUARANTEED. THIS MEDICAL DEVICE MUST BE STERILE IN ORDER TO SERVE ITS PURPOSE FULFILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462541 | SOL-M CATHETER TIP SYRINGE | SYRINGE | FMI | SOL-MILLENNIUM MEDICAL INC | 180100CT | 04202041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |