FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 3101646
·
Received May 3, 2013
Report
- Report Number
- 1721504-2013-00092
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 5, 2013
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DRS
- PMA / PMN Number
- K913682
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED A FOREIGN OBJECT WAS IDENTIFIED IN THE FEMALE CONNECTOR OF THE HIGH PRESSURE TUBING WITHIN THE KIT DURING THEIR INITIAL INSPECTION OF RECEIVED PRODUCT. THE DEVICE WAS NOT SENT TO A USER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195063 | MERIT CUSTOM KIT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DRS | MERIT MEDICAL SYSTEMS, INC. | H443586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |