FDA Adverse Event
Malfunction
Summary report: N
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
MDR report key: 1201229
·
Received October 20, 2008
Report
- Report Number
- 1423500-2007-00001
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- January 1, 2007
- Report Date
- January 1, 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 03 2007. EVALUATION SUMMARY;RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT. THERE HAS BEEN CORRECTIVE AND PREVENTATIVE ACTION TAKEN RELATIVE TO THIS MATTER, CAPA. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED TRANSFER SET, A BROKEN SPIKE WAS DISCOVERED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH | TRANSFER SET | KDJ | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |