FDA Adverse Event
Malfunction
Summary report: N
INSET I 60/9 GREY T-CAP
MDR report key: 20181408
·
Received September 10, 2024
Report
- Report Number
- 3003442380-2024-24784
- Event Type
- Malfunction
- Date Received
- September 10, 2024
- Date of Event
- July 16, 2024
- Report Date
- December 16, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244026032
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR DEVICE 2 OF 2.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUE WITH 2 INFUSION SETS AS THE TUBING DETACHED FROM THE CONNECTOR ONN (B)(6) 2024 AND (B)(6) 2024. THE SETS TUBING DETACHED AFTER BEING IN USE FOR APPROXIMATELY 20 MINUTES TO 24 HOURS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2336378 | INSET I 60/9 GREY T-CAP | INSET I 2-PACK 60/9 GREY TCAP | FPA | UNOMEDICAL A/S | 1010899 | 5381388 | 05705244026032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female |