FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 20317876
·
Received September 27, 2024
Report
- Report Number
- 3003442380-2024-27381
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Date of Event
- August 14, 2024
- Report Date
- August 29, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018365
- PMA / PMN Number
- K061374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1991008, DEVICE 3 OF 6.
Description of Event or Problem · 0
REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED ON (B)(6) 2024 THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA WAS KINKED WAS KINKED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT ABDOMEN. THE PATIENT REGULARLY ROTATED THE SITE LOCATION. 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 |
|---|---|---|---|---|---|---|---|
| 1432590 | AUTOSOFT 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | 6005843 | 05705244018365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |