FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC EXTENDED INFUSION SET
MDR report key: 19686805
·
Received July 7, 2024
Report
- Report Number
- 8021545-2024-01740
- Event Type
- Malfunction
- Date Received
- July 7, 2024
- Date of Event
- June 5, 2024
- Report Date
- July 7, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244023048
- PMA / PMN Number
- K210544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
(B)(4). INITIAL AND FINAL MDR 1905676 - MDR 8021545-2024-01740- DEVICE 1 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET FELL OFF. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170375 | MEDTRONIC EXTENDED INFUSION SET | UNO EWIS BLUE 60/9 HCAP 1-PK IN | FPA | UNOMEDICAL A/S | 1002823 | 6002761 | 05705244023048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |