FDA Adverse Event
Malfunction
Summary report: N
MERIT HEMOSTASIS VALVE
MDR report key: 1854304
·
Received September 3, 2010
Report
- Report Number
- 9616662-2010-00041
- Event Type
- Malfunction
- Date Received
- September 3, 2010
- Date of Event
- July 28, 2010
- Report Date
- August 11, 2010
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DTL
- PMA / PMN Number
- K993057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVAL/INVESTIGATION. THE SECOND REPORTED POTENTIAL LOT NUMBER IS F775105, EXPIRATION DATE - 12/31/2012, MANUFACTURE DATE - 2/2010. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. EVAL, CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE ROTATOR BROKE DURING INJECTION FROM SIDE PORT. INJECTOR SETTINGS: FLOW - 6 ML/SEC, VOLUME - 8 ML, PRESSURE 400 PSI. CUSTOMER REPORTED TWO LOT NUMBERS. CUSTOMER IS NOT SURE WHICH LOT NUMBER WAS USED. THERE WAS NO REPORT OF HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIT HEMOSTASIS VALVE | ADAPTER, STOPCOCK, MANIFOLD FITTING | DTL | MERIT MEDICAL SYSTEMS, INC. | W770051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AVANTA INJECTOR| CONTRAST MEDIA| 4FR CATHETER |