FDA Adverse Event
Malfunction
Summary report: N
PVC, CLEAR, CONTRAST INJECTION TUBING
MDR report key: 2192952
·
Received July 21, 2011
Report
- Report Number
- 1721504-2011-00230
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 28, 2011
- 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 IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. CONCLUSION: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A LEFT VENTRICULOGRAM PROCEDURE, THE ROTATOR BROKE AT 750 PSI. NO HARM OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PVC, CLEAR, CONTRAST INJECTION TUBING | DISPLAY, CATHODE RAY-TUBE, MEDICAL | DXJ | MERIT MEDICAL SYSTEMS, INC. | F753277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4FR CATHETER |