FDA Adverse Event
Malfunction
Summary report: N
CARDIOVASCULAR PROCEDURE KIT
MDR report key: 2190923
·
Received July 19, 2011
Report
- Report Number
- 1212122-2011-00122
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 24, 2011
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- Product Code
- OEZ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; HOWEVER, INVENTORY SAMPLES WERE EVALUATED AND THE COMPLAINT WAS CONFIRMED. THE SAMPLE WAS FLOW TESTED AND LEAKED WHEN THE CONTROL KNOB WAS PRESSED DOWN. THE LEAK WILL STOP ONCE THE CONTROL KNOB IS PLACED BACK IN ITS RESTING POSITION. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATE AWARENESS TRAINING. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND F/U. (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING NON-CLINICAL ACTIVITY, THE 3T PRESSURE RELEASE VALVE LEAKED. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOVASCULAR PROCEDURE KIT | CONVENIENCE TUBING PACK | OEZ | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION | NF31 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |