FDA Adverse Event
Malfunction
Summary report: N
CUSTOM KIT, CT-SET
MDR report key: 959866
·
Received May 2, 2007
Report
- Report Number
- 9616662-2007-00004
- Event Type
- Malfunction
- Date Received
- May 2, 2007
- Date of Event
- February 20, 2007
- Report Date
- February 20, 2007
- Manufacturer
- MERIT MEDICAL IRELAND, LTD.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS INCIDENT WAS REPORTED IN MDR #9616662-2007-00001 (DEVICE 3). DURING A CONVERSATION WITH REP (FDA), IT WAS RECOMMENDED A SEPARATE REPORT BE FILED.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THAT DURING A CONTRAST INJECTION PROCEDURE THERE WERE 3 FAILURES ON 2 PATIENTS WITH CT KITS. IT WAS REPORTED THAT CONTRAST WAS SPURTING OUT FROM ONE OF THE VALVES OR FROM THE TUBING BETWEEN THE VALVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUSTOM KIT, CT-SET | FLUID ADMINISTRATION SYSTEM | FPA | MERIT MEDICAL IRELAND, LTD. | NA | W496873 OR C348740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PRESSURE INJECTOR (EZEM FASTLOAD SYRINGE)| CT TRANSFER LINE (K08-00801) |