BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD IV SOLUTION ADMIN SET

    MDR report key: 1973251 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00501
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER OF A FLO-GARD IV SET THAT HAD A BROKEN SPIKE. THIS SET WAS INITIALLY PRIMED WITH SALINE; AFTERWARDS THE SET WAS REMOVED FROM THE SALINE BAG AND THEN INSERTED INTO A CYTOTOXIC BAG. WHEN THE SPIKE WAS INSERTED, THE SPIKE COMPONENT OF THE SET BROKE. THIS REPORTED CONDITION OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD IV SOLUTION ADMIN SET SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE, CYTOTOXIC