FDA Adverse Event
Malfunction
Summary report: N
CAPD SOLUTION TRANSFER SET FOR UV-FLASH
MDR report key: 1201225
·
Received October 20, 2008
Report
- Report Number
- 1423500-2007-00038
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- December 18, 2006
- Report Date
- December 22, 2006
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- 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 FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 23 2007.
Description of Event or Problem · 1
BAXTER PRODUCT SURVEILLANCE RECEIVED NOTIFICATION OF AN INCIDENT FROM THE INTERNATIONAL AFFILIATE IN 2007. INT'L AFFILIATE REPORTED LEAKAGE FROM A SILICONE TUBING AFTER 60 DAYS OF USE. THE PRODUCT WAS NEW AND THE SAMPLE IS NOT AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER THE INTERNATIONAL AFFILIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPD SOLUTION TRANSFER SET FOR UV-FLASH | UV TRANSFER SETS | KDJ | BAXTER HEALTHCARE CORPORATION | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |