FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19423435
·
Received May 30, 2024
Report
- Report Number
- 3003442380-2024-04642
- Event Type
- Malfunction
- Date Received
- May 30, 2024
- Date of Event
- April 27, 2024
- Report Date
- May 30, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- 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 1875257 - MDR 3003442380-2024-04642 - DEVICE 2 OF 3
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SOUTH AFRICA IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET CANNULA BENT EVENTS ON (B)(6) 2024. EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INSERTION SITE WAS AT UPPER BUTTOCKS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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 |
|---|---|---|---|---|---|---|---|
| 1126667 | AUTOSOFT 90 | UNO INSET II 60/6 BLUE TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002823 | 6003151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |