FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 20082689
·
Received August 28, 2024
Report
- Report Number
- 3003442380-2024-22657
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Date of Event
- May 12, 2024
- Report Date
- July 29, 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 1952504 - MDR 3003442380-2024- 22657 - DEVICE 7 OF 8.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE SPAIN FROM (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA WAS KINKED WITHIN 3 HOURS OF INSERTION. THE INFUSION SET WAS USED FOR FEW HOURS. THE ISSUE GOT RESOLVED BY REPLACING THE 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 AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1478994 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002817 | 6004248 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |