FDA Adverse Event
Malfunction
Summary report: N
CLEARLINK PACLITAXEL SET
MDR report key: 1193071
·
Received October 13, 2008
Report
- Report Number
- 6000001-2007-01799
- Event Type
- Malfunction
- Date Received
- October 13, 2008
- Date of Event
- January 5, 2007
- Report Date
- January 16, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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 JAN 24, 2007. DEVICE IS NOT AVAILABLE FOR EVALUATION. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.
Description of Event or Problem · 1
CUSTOMER REPORTED TUBING SEPARATED FROM THE DRIP CHAMBER ON THIS SET DURING PATIENTS TAXOL TREATMENT. NO PATIENT INJURY HAS BEEN REPORTED. SET WAS REPLACED AND PATIENTS THERAPY CONTINUED. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEARLINK PACLITAXEL SET | INTRAVASCULAR ADMINISTRATION SET | FPA | BAXTER HEALTHCARE CORPORATION | N/A | R06F22013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |