FDA Adverse Event
Malfunction
Summary report: N
CADD
MDR report key: 14064969
·
Received April 9, 2022
Report
- Report Number
- 3012307300-2022-06109
- Event Type
- Malfunction
- Date Received
- April 9, 2022
- Report Date
- April 9, 2022
- Manufacturer
- ST PAUL
- Product Code
- FPA
- UDI-DI
- 10610586027239
- PMA / PMN Number
- K040636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
(3/4 REFERENCE (B)(6) FOR RELATED COMPLAINTS) (DOCUMENTING THIRD EVENT) PER MEDWATCH MW5107248: PATIENT REPORTED SHE HAD ISSUES WITH 4 CASSETTES OVER THE PAST MONTH. SHE KEPT THE CASSETTES BUT ONLY HAS THE LOT INFORMATION FOR TWO OF THEM: 4203283 AND 4173645. NO PATIENT INJURY. NO OTHER INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 160069 | CADD | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ST PAUL | 21-7302-24 | 10610586027239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |