FDA Adverse Event
Malfunction
Summary report: N
CLEAR, PVC CONTRAST INJECTION LINE
MDR report key: 1648989
·
Received March 26, 2010
Report
- Report Number
- 1721504-2010-00070
- Event Type
- Malfunction
- Date Received
- March 26, 2010
- Date of Event
- February 19, 2010
- Report Date
- March 3, 2010
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DXJ
- PMA / PMN Number
- K883718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE SUSPECT DEVICE HAS NOT BEEN RECEIVED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. DEVICE HISTORY RECORD WAS REVIEWED; COMPLAINT DATABASE WAS REVIEWED. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL IS COMPLETED.
Description of Event or Problem · 1
THE ROTATOR BROKE WHILE PERFORMING A LEFT VENTRICULOGRAM PROCEDURE USING A POWER INJECTOR. THERE WAS NO REPORT OF HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEAR, PVC CONTRAST INJECTION LINE | DISPLAY, CATHODE-RAY-TUBE, MEDICAL | DXJ | MERIT MEDICAL SYSTEMS, INC. | F693783 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA |