FDA Adverse Event
Malfunction
Summary report: N
CADD CASSETTE RESERVOIR
MDR report key: 11130854
·
Received January 7, 2021
Report
- Report Number
- 3012307300-2021-00176
- Event Type
- Malfunction
- Date Received
- January 7, 2021
- Date of Event
- December 9, 2020
- Report Date
- March 8, 2021
- Manufacturer
- ST PAUL
- Product Code
- FPA
- UDI-DI
- 10610586027239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: TWO CADD CASSETTE RESERVOIRS WERE RETURNED FOR THE EVALUATION OF LEAKAGE. THE UNITS WERE VISUALLY INSPECTED AND NO DAMAGES NOR OTHER WORKMANSHIP DEFECTS WERE APPRECIATED ON THE SAMPLES RECEIVED. A FUNCTIONAL TESTING WAS PERFORMED WHERE A SYRINGE WAS USED TO INFUSE WATER INTO THE CASSETTE BAG. A LEAK WAS DETECTED FLEEING FROM THE BONDING BETWEEN THE PUMP TUBE AND THE BAG IN BOTH SAMPLES. ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE.
Additional Manufacturer Narrative · 1
POSSIBLE LOT NUMBERS: 4013375 OR 4037752. (B)(6). OCCUPATION: CSP SUPERVISOR.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD CASSETTE RESERVOIR WAS LEAKING WAS LEAKING IMMEDIATELY ON USE. THERE WAS NO PATIENT OR CLINICIAN INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30333 | CADD CASSETTE RESERVOIR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ST PAUL | 21-7302-24 | 10610586027239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |