FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 21879810
·
Received April 22, 2025
Report
- Report Number
- 3003442380-2025-06619
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- March 20, 2025
- Report Date
- March 25, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V
- 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 (B)(4) - DEVICE 2 OF 3.
Description of Event or Problem · 0
(B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2025. THE EVENT OCCURRED WITHIN THREE HOURS AFTER INSERTION. THE INSERTION SITE WAS THIGH AND ABDOMEN. THE INFUSION SET WAS IN USE FOR 3 OR MOE HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY 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 WAS AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1338542 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL DEVICES S.A. DE C.V | 1001680 | 6008254 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female |