FDA Adverse Event
Malfunction
Summary report: N
MINIMED QUICK-SET
MDR report key: 19506924
·
Received June 10, 2024
Report
- Report Number
- 3003442380-2024-07485
- Event Type
- Malfunction
- Date Received
- June 10, 2024
- Date of Event
- May 10, 2024
- Report Date
- June 10, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244017450
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1884612 - MDR 3003442380-2024-07485 - DEVICE 1 OF 6.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN PUERTO RICO, U.S.. IT WAS REPORTED THAT PATIENT FACED 6 INFUSION SET CANNULA BENT EVENTS ON (B)(6) 2024. THE INSERTION SITE WAS AT ARM. INFUSION SET HAS BEEN USED FOR 1 DAY. CUSTOMER HAD SUFFICIENT SUBCUTANEOUS TISSUE WHERE SET WAS INSERTED. 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 |
|---|---|---|---|---|---|---|---|
| 859336 | MINIMED QUICK-SET | UNO QUICK-SET 60/6 SC1 MECA | FPA | UNOMEDICAL A/S | MMT-399A | 6004472 | 05705244017450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |