FDA Adverse Event
Malfunction
Summary report: N
UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN
MDR report key: 1081773
·
Received July 18, 2008
Report
- Report Number
- 1423500-2008-00665
- Event Type
- Malfunction
- Date Received
- July 18, 2008
- Date of Event
- May 28, 2008
- Report Date
- May 30, 2008
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- PMA / PMN Number
- K883239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF A LEAK FROM THE TUBING OF A TRANSFER SET. THIS WAS DUE TO TWO TUBING PINHOLES. THE ROOT CAUSE WAS UNDETERMINED. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS, AND TAKE CORRECTIVE / PREVENTATIVE ACTION AS APPROPRIATE.
Description of Event or Problem · 1
BAXTER REPORTED A LEAK FROM THE SILICONE TUBING. NO 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 |