FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 5051715
·
Received September 2, 2015
Report
- Report Number
- 9616662-2015-00011
- Event Type
- Malfunction
- Date Received
- September 2, 2015
- Date of Event
- August 7, 2015
- Report Date
- August 7, 2015
- Manufacturer
- MERIT MEDICAL IRELAND LTD.
- Product Code
- DQO
- PMA / PMN Number
- K913682
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE AFFECTED DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
NO DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. BECAUSE THE UNIT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE IS RETURNED IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED AND A FOLLOW UP SUBMITTED.
Description of Event or Problem · 1
THE USER REPORTED THAT AIR WAS PULLED INTO THE SYRINGE THROUGH THE CONTRAST TUBING. THE AIR WAS CLEARED FROM THE SYSTEM. NO AIR WAS INJECTED INTO THE PATIENT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583060 | MERIT CUSTOM KIT | CUSTOM KIT | DQO | MERIT MEDICAL IRELAND LTD. | K772420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |