FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 1571323
·
Received December 8, 2009
Report
- Report Number
- 1721504-2009-00177
- Event Type
- Malfunction
- Date Received
- December 8, 2009
- Date of Event
- October 19, 2009
- Report Date
- November 9, 2009
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DQO
- PMA / PMN Number
- K913682
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: DEVICE EVALUATION NOT COMPLETED. CONCLUSIONS - A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE ROTATOR BROKE DURING INJECTION WITH MICRO CATHETER. THERE WAS NO O-RING IN THE ROTATOR. FLOW: 2ML/SEC, VOL: 10ML, PRESSURE LIMIT 750 PSI. THE KIT WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIT CUSTOM KIT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | MERIT MEDICAL SYSTEMS, INC. | F636873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA| MICRO CATHETER |