FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19490036
·
Received June 7, 2024
Report
- Report Number
- 3003442380-2024-06821
- Event Type
- Malfunction
- Date Received
- June 7, 2024
- Date of Event
- March 9, 2024
- Report Date
- June 7, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018129
- 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 1882139 - DEVICE 2 OF 5.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON (B)(6) 2024, IT WAS REPORTED THAT FIVE INFUSION SETS CANNULA WERE KINKED. THE SYMPTOMS WERE NOTICED WITHIN THREE HOURS OF INSERTION. THE INFUSION SET WAS IN USE FOR FEW HOURS. THE EVENTS OCCURRED ON (B)(6) 2024, (B)(6) 2024,(B)(6) 2024, (B)(6) 2024 AND (B)(6) 2024. 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 |
|---|---|---|---|---|---|---|---|
| 1264991 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002817 | 5408438 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |