FDA Adverse Event
Malfunction
Summary report: N
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
MDR report key: 1230765
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00097
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- January 26, 2007
- Report Date
- January 30, 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
.
Description of Event or Problem · 1
BAXTER PRODUCT SURVEILLANCE RECEIVED NOTIFICATION OF AN INCIDENT FROM THE INTERNATIONAL AFFILIATE IN 2007. BAXTER REPORTED LEAKAGE FROM A SILICONE TUBING AFTER 30 DAYS OF USE. 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 | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |