FDA Adverse Event
Malfunction
Summary report: N
INFUSION DEVICES - UNKNOWN - IDD
MDR report key: 20617215
·
Received November 6, 2024
Report
- Report Number
- 3003442380-2024-30721
- Event Type
- Malfunction
- Date Received
- November 6, 2024
- Date of Event
- September 27, 2024
- Report Date
- October 8, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR (B)(4) - DEVICE 1 OF 5.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON 27-SEPTEMBER-2024, IT WAS REPORTED BY THE PATIENT THAT FIVE INFUSIONS SET CANNULA WAS KINKED WITHIN 3 HOURS OF INSERTION. EVENT WAS OCCURRED ON 27/09/2024, 27/09/2024, 28/09/2024, 28/09/2024 AND 29/09/2024. PATIENT REPLACED 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 WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1418282 | INFUSION DEVICES - UNKNOWN - IDD | INFUSION DEVICES - UNKNOWN | FPA | UNOMEDICAL A/S | INFUSION DEVICES - UNKNOWN - IDD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |