FDA Adverse Event
Malfunction
Summary report: N
INFUSION DEVICES - UNKNOWN
MDR report key: 19890329
·
Received August 2, 2024
Report
- Report Number
- 3003442380-2024-18704
- Event Type
- Malfunction
- Date Received
- August 2, 2024
- Date of Event
- May 20, 2024
- Report Date
- August 2, 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) - MDR DEVICE 4 OF 6.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. ON 20-MAY-2024, IT WAS REPORTED BY THE PATIENT THAT SIX INFUSION SET WAS KINKED WITHIN 3 HOURS OF INSERTION. EVENT WAS OCCURRED ON 20/05/2024, 24/05/2024, 29/05/2024, 10/06/2024, 25/06/2024, AND 30/06/2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN 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 |
|---|---|---|---|---|---|---|---|
| 984896 | INFUSION DEVICES - UNKNOWN | INFUSION DEVICES - UNKNOWN | FPA | UNOMEDICAL A/S | INFUSION DEVICES - UNKNOWN | 6003209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |