FDA Adverse Event
Malfunction
Summary report: N
UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN
MDR report key: 1003740
·
Received February 21, 2008
Report
- Report Number
- 1423500-2008-00094
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- December 6, 2007
- Report Date
- December 6, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- PMA / PMN Number
- K883239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF LEAKAGE FROM THE SILICONE TUBING ON A TRANSFER SET. THE ROOT CAUSE WAS A CUT/SLICE/HOLE IN THE TUBING WALL. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE AND TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE.
Description of Event or Problem · 1
REPORTER REPORTED LEAKAGE FROM THE SILICONE TUBING ON A TRANSFER SET. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN | TRANSFER SET / 78KDJ | KDJ | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |