FDA Adverse Event
Malfunction
Summary report: N
MARQUIS SERIES STOPCOCKS
MDR report key: 1791324
·
Received August 6, 2010
Report
- Report Number
- 1721504-2010-00216
- Event Type
- Malfunction
- Date Received
- August 6, 2010
- Date of Event
- July 13, 2010
- Report Date
- July 13, 2010
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DTL
- PMA / PMN Number
- K934123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE CUSTOMER WILL NOT BE RETURNING ANY DEVICES FOR EVAL/INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE CONDUCTED. LOT NUMBER NOT PROVIDED, UNABLE TO CONDUCT DEVICE HISTORY RECORD REVIEW. CONCLUSIONS: OTHER, A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE STOPCOCK BREAKS WHEN THEY APPLY 500 PSI. THIS HAPPENED WITH FOUR (4) UNITS FROM THE SAME LOT. NO REPORT OF HARM OR INJURY. THIS IS ONE OF FOUR (4) REPORTS FOR THIS COMPLAINT. 1721504-2010-00215, 1721504-2010-00217, 1721504-2010-00218.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARQUIS SERIES STOPCOCKS | ADAPTER, STOPCOCK, MANIFOLD FITTING | DTL | MERIT MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HP301E| INJECTOR| CONTRAST MEDIA |