FDA Adverse Event
Malfunction
Summary report: N
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
MDR report key: 1201865
·
Received October 21, 2008
Report
- Report Number
- 1423500-2007-00058
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- January 3, 2007
- Report Date
- January 15, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- 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 FEB 07 2007.
Description of Event or Problem · 1
BAXTER PRODUCT SURVEILLANCE RECEIVED NOTIFICATION OF AN INCIDENT FROM THE INTERNATIONAL AFFILIATE IN 2007. BAXTER REPORTED A BROKEN SPIKE AFTER 3 MONTHS 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 |