FDA Adverse Event
Malfunction
Summary report: N
POLYURETHANE CONTRAST INJECTION LINE
MDR report key: 1994313
·
Received January 14, 2011
Report
- Report Number
- 1721504-2011-00014
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 21, 2010
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DTR
- PMA / PMN Number
- K932251
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE SUSPECT DEVICES WILL NOT BE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. EVAL METHOD: DEVICE HISTORY RECORD WAS REVIEWED.
Description of Event or Problem · 1
THE ROTATOR BREAKS WHEN INJECTING CONTRAST. NO HARM OR INJURY WAS REPORTED. THE CUSTOMER REPORTED 3 DEFECTIVE DEVICES/EVENTS BUT DID NOT PROVIDE SEPARATE INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS. THE CUSTOMER IS NOT EXPECTED TO RETURN ANY USED DEVICES FOR EVAL. THEREFORE, THIS SINGLE FORM FDA 3500A REPORT WILL BE SUBMITTED FOR THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYURETHANE CONTRAST INJECTION LINE | DISPLAY, CATHODE-RAY TUBE, MEDICAL | DTR | MERIT MEDICAL SYSTEMS, INC. | F731031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA |