FDA Adverse Event
Malfunction
Summary report: N
CLEAR, PVC CONTRAST INJECTION LINE
MDR report key: 2013823
·
Received February 4, 2011
Report
- Report Number
- 1721504-2011-00037
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DXJ
- PMA / PMN Number
- K883718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE EVALUATION HAS NOT BEEN COMPLETED. A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. EVALUATION: CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TUBING CRACKED AT THE MALE LURE END DURING POWER INJECTION. NO HARM OR INJURY WAS REPORTED.
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. | H186063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA |