FDA Adverse Event
Malfunction
Summary report: N
TRUSTEEL
MDR report key: 19935733
·
Received August 7, 2024
Report
- Report Number
- 3003442380-2024-19842
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- June 27, 2024
- Report Date
- July 9, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018518
- PMA / PMN Number
- K041545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1961239 - MDR 3003442380- 2024 - 19842 - DEVICE 2 OF 2.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED ON 27-JUN-2024 SIX INFUSION SETS HAVE OCCLUSION ISSUE. TROUBLESHOOTING WAS PERFORMED AND OCCLUSION WAS DETERMINED AT SITE AND SKIN IRRITATION ALSO OCCURRED. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1025896 | TRUSTEEL | UNO CONTACT DETACH G29 80/8TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002836 | 6003567 | 05705244018518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female |