FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC EXTENDED INFUSION SET
MDR report key: 19916814
·
Received August 6, 2024
Report
- Report Number
- 8021545-2024-03010
- Event Type
- Malfunction
- Date Received
- August 6, 2024
- Date of Event
- July 7, 2024
- Report Date
- August 7, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244023284
- PMA / PMN Number
- K210544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1932718 - MDR 8021545-2024-03010 - DEVICE 2 OF 3. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: CANADA.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED AN 3 INFUSION SETS LEAKAGE EVENT AT THE SITE. THE INFUSION SET WAS IN USE FOR 4 DAYS. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1841551 | MEDTRONIC EXTENDED INFUSION SET | UNO EWIS BLUE 60/9 HCAP 3-PK INT | FPA | UNOMEDICAL A/S | MMT-441AH | UNKNOWN | 05705244023284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |