BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK VENTED PACLITAXEL SET

    MDR report key: 1193067 · Received October 13, 2008

    Report

    Report Number
    6000001-2007-01061
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    January 9, 2007
    Report Date
    January 9, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Removal / Correction Number
    2007-0008-MD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 10, 2007. EVALUATION SUMMARY: A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE, SHOULD THE REPORTED DEVICE BE RETURNED AND EVALUATED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CUSTOMER'S REPORTED CONDITION OF SEPARATION WAS CONFIRMED. THE CONCLUSION TO THE INVESTIGATION FOUND THAT THE MOST PROBABLE ROOT CAUSE WAS INSUFFICIENT SOLVENT IN THE DRIP CHAMBER TO BUSHING BOND. IN ADDITION, AN URGENT PRODUCT RECALL LETTER WAS SENT OUT TO CUSTOMERS ON 02/16/2007.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM FACILITY CONTACT. CUSTOMER REPORTS THE TUBING SEPARATED FROM THE DRIP CHAMBER BEFORE PATIENT USE. NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK VENTED PACLITAXEL SET CLEARLINK FPA BAXTER HEALTHCARE CORPORATION NA R06F22013

    Patients

    Seq Age Sex Outcome Treatment
    1