FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 20606811
·
Received November 5, 2024
Report
- Report Number
- 3003442380-2024-30708
- Event Type
- Malfunction
- Date Received
- November 5, 2024
- Date of Event
- September 2, 2024
- Report Date
- October 8, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 2030786, DEVICE 5 OF 9.
Description of Event or Problem · 0
REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT PATIENT FACED NINE INFUSION SET KINKED CANNULA EVENTS EACH ON 02-SEP, 03-SEP, 07-SEP, 18-SEP, 19-SEP, 23-SEP, 26-SEP AND TWICE ON 12-SEP. EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE SET WAS IN USE FOR A FEW HOURS. PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY DO NOT SEE 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 |
|---|---|---|---|---|---|---|---|
| 49626 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002817 | 6004910 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |