FDA Adverse Event
Malfunction
Summary report: N
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
MDR report key: 1201903
·
Received October 21, 2008
Report
- Report Number
- 1423500-2007-00040
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- January 7, 2007
- Report Date
- January 11, 2007
- 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 EARLY 2007. REPORTER REPORTED A LEAKAGE FROM A SILICONE TUBING AFTER 24 DAYS OF USE. THE PRODUCT WAS NEW AND THE SAMPLE IS AVAILABLE AND HAS BEEN REQUESTED. 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 (SHORT) FOR UV-FLASH | UV TRANSFER SETS | KDJ | BAXTER HEALTHCARE CORPORATION | NA | H06J09062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |