FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 4190035
·
Received September 18, 2014
Report
- Report Number
- 1721504-2014-00215
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DQO
- PMA / PMN Number
- K994253
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: ONE UNUSED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND TWO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE WAS EXAMINED VISUALLY, PARTICULATE LARGER THAN THE ACCEPTANCE CRITERIA WAS FOUND. THE COMPLAINT WAS CONFIRMED FOR THIS DEVICE. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. CORRECTIVE ACTION IS IN PROCESS.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT A FOREIGN OBJECT WAS IDENTIFIED IN THE BARREL OF THE SYRINGE INCLUDED IN 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 |
|---|---|---|---|---|---|---|---|
| 577686 | MERIT CUSTOM KIT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | MERIT MEDICAL SYSTEMS, INC. | H635486 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |