FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19808338
·
Received July 23, 2024
Report
- Report Number
- 3003442380-2024-15903
- Event Type
- Malfunction
- Date Received
- July 23, 2024
- Date of Event
- June 10, 2024
- Report Date
- July 24, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 06-10-12024 IT WAS REPORTED BY THE PATIENT THAT INFUSION SET CANNULA WAS KINKED WITHIN 3 HOURS OF INSERTION THE SITE WHERE INFUSION SET WAS INSERTED WAS ABDOMEN RIGHT SIDE. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 965046 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | UNKNOWN | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female |