BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED PACLITAXEL SET W/POLYTBG NON-DEHP PUM SEGMENT 22FLT

    MDR report key: 1943122 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06506
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 19, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE THE REPORTED CONDITION OF NO FLOW WAS NOT CONFIRMED OR DUPLICATED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED AND NO DEVIATIONS WERE FOUND. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A LOWER CLEARLINK PORT THAT WAS UNABLE TO FLUSH OR RUN FLUID AND LEAKING BACK THROUGH THE LINE. THE REPORTED CONDITION OCCURRED DURING PRIMING. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED PACLITAXEL SET W/POLYTBG NON-DEHP PUM SEGMENT 22FLT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R09H08031

    Patients

    Seq Age Sex Outcome Treatment
    1