FDA Adverse Event
Malfunction
Summary report: N
CLEAR, PVC CONTRAST INJECTION LINE
MDR report key: 1915321
·
Received November 2, 2010
Report
- Report Number
- 1721504-2010-00366
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- August 10, 2010
- Report Date
- October 6, 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 EVALUATION: THE EVALUATION/INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. EVALUATION: 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 A LEFT VENTRICULOGRAM PROCEDURE. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED THREE (3) DEFECTIVE DEVICES BUT HAS NOT PROVIDED ANY ADDITIONAL INFORMATION OR CLINICAL DETAILS FOR THE ADDITIONAL EVENTS. THE CUSTOMER RETURNED ONE DEVICE. THEREFORE, THIS SINGLE REPORT WILL BE SUBMITTED FOR THIS COMPLAINT.
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. | F739745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA |