FDA Adverse Event
Malfunction
Summary report: N
POLYURETHANE CONTRAST INJECTION LINE
MDR report key: 1942660
·
Received December 23, 2010
Report
- Report Number
- 1721504-2010-00460
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Date of Event
- October 29, 2010
- Report Date
- November 29, 2010
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DXJ
- PMA / PMN Number
- K883718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE HIGH PRESSURE TUBING LINES CAME DISCONNECTED FROM THE INJECTOR SYRINGE DURING INJECTION AND SPRAYED CONTRAST. NO HARM OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYURETHANE CONTRAST INJECTION LINE | DISPLAY, CATHODE-RAY TUBE, MEDICAL | DXJ | MERIT MEDICAL SYSTEMS, INC. | H135847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA |