FDA Adverse Event
Malfunction
Summary report: N
UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN
MDR report key: 1130044
·
Received August 19, 2008
Report
- Report Number
- 1423500-2008-00751
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 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 IN THE TUBING OF A TRANSFER SET. THE ROOT CAUSE WAS A SMALL 'V' SHAPED CRACK. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE OF TRENDS, AND TAKE CORRECTIVE / PREVENTATIVE ACTION AS APPROPRIATE.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATER REPORTED A LEAK FROM THE SILICONE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.
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 |