FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 20145268
·
Received September 5, 2024
Report
- Report Number
- 3003442380-2024-24288
- Event Type
- Malfunction
- Date Received
- September 5, 2024
- Date of Event
- July 15, 2024
- Report Date
- August 9, 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
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1963831- MDR 3003442380-2024-24288- DEVICE 10 OF 12
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6)2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED TEWLVE INFUSION SETS CANNULA KINKED EVENTS WITHIN 3 HOURS AFTER INSERTION. THE SITE OF INSERTION WAS ABDOMEN DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1913046 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6003981 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |