FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 3050222
·
Received April 5, 2013
Report
- Report Number
- 1721504-2013-00072
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DQO
- PMA / PMN Number
- K913682
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE USER REPORTED THAT AIR BUBBLES ENTERED THE SYSTEM WHILE PREPARING THE DEVICE FOR USE. THE USER STATED THAT THE BONDED CONTRAST TUBING IS NOT SEALED OR CRACKED AT THE AREA BETWEEN THE TUBING AND THE MANIFOLD JUNCTION. THE ENTIRE KIT WAS DISCARDED AND A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THE SUSPECT KIT WAS NOT USED ON THE PATIENT. NO HARM OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139769 | MERIT CUSTOM KIT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | MERIT MEDICAL SYSTEMS, INC. | H422849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MANIFOLD |