FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19489361
·
Received June 7, 2024
Report
- Report Number
- 3003442380-2024-06963
- Event Type
- Malfunction
- Date Received
- June 7, 2024
- Date of Event
- April 27, 2023
- Report Date
- June 7, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016651
- 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 1882080 - DEVICE 2 OF 6
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED SIMILAR EVENTS OF BENT CANNULA WITH SIX INFUSION SETS. THE SYMPTOMS WERE NOTICED 3 OR MORE HOURS AFTER INSERTION. THE SET WAS IN USE FOR 1 DAY. THE SITE OF INSERTION WAS ABDOMEN AND WAS ROTATED REGULARLY. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN. UNOMEDICAL 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 AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2107217 | AUTOSOFT XC | UNO INSET I 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001681 | 5408261 | 05705244016651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Male |