FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 4173468
·
Received October 10, 2014
Report
- Report Number
- 1721504-2014-00241
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 12, 2014
- Report Date
- September 12, 2014
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DQO
- PMA / PMN Number
- K913682
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONE UNUSED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE RETURNED DEVICE WAS VISUALLY EXAMINED AND HE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MFG PROCESS.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED A HOLE IN THE CLEAR FILM OF THE PACKAGING. THIS WAS IDENTIFIED 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 |
|---|---|---|---|---|---|---|---|
| 642753 | MERIT CUSTOM KIT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | MERIT MEDICAL SYSTEMS, INC. | H670456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |