FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC EXTENDED
MDR report key: 19445639
·
Received June 3, 2024
Report
- Report Number
- 8021545-2024-00771
- Event Type
- Malfunction
- Date Received
- June 3, 2024
- Date of Event
- April 30, 2024
- Report Date
- May 31, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244022683
- PMA / PMN Number
- K210544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: POLAND. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD # 6002694 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT PATIENT FACED INFUSION SET NOT STICKING EVENT ON 30-APR-2024. EVENT OCCURED AFTER 3-4 DAYS OF USE. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1939695 | MEDTRONIC EXTENDED | UNO EWIS BLUE 60/6 HCAP 10PK INT | FPA | UNOMEDICAL A/S | MMT-431A | UNKNOWN | 05705244022683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |