FDA Adverse Event
Malfunction
Summary report: N
UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN
MDR report key: 1243209
·
Received November 10, 2008
Report
- Report Number
- 1423500-2008-00896
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 11, 2008
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- 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
(B) (4). EVALUATION SUMMARY: RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF LEAKAGE FROM THE SILICONE TUBING ON A TRANSFER SET. THE ROOT CAUSE WAS A PINHOLE IN THE TUBING. 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
BAXTER (B) (4) REPORTED A LEAK COMING FROM THE SILICONE TUBING ON A TRANSFER SET AFTER 70 DAYS OF USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN | 78KDJ | KDJ | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |