FDA Adverse Event
Malfunction
Summary report: N
UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN
MDR report key: 1213147
·
Received October 29, 2008
Report
- Report Number
- 1423500-2007-88859
- Event Type
- Malfunction
- Date Received
- October 29, 2008
- Date of Event
- June 28, 2007
- Report Date
- June 28, 2007
- 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
THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 12, 2007.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: EVALUATION SUMMARY: THE REPORTED EVENT COULD NOT BE CONFIRMED IN THE LAB. THERE ARE NO FURTHER MEASURES TO BE TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE AND TAKE CORRECTIVE / PREVENTATIVE MEASURES AS APPROPRIATE.
Description of Event or Problem · 1
BAXTER REPORTED THAT THE SPIKE ON A TRANSFER SET WAS BROKEN BY A CLEAN FLASH DEVICE. 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 |