BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD IV SOLUTION ADMIN SET

    MDR report key: 2032000 · Received March 28, 2011

    Report

    Report Number
    6000001-2011-02253
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE HAS BEEN RECEIVED AND IS AVAILABLE FOR EVALUATION. ONCE THE SAMPLE HAS BEEN EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE TUBING BEING CUT. THE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO HAVE BEEN CAUSED BY THE TUBE PROTRUDING OUT OF THE PLASTIC POUCH. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT UPON OPENING A FLOGARD IV SOLUTION ADMINISTRATION SET IT WAS NOTICED THAT PART OF THE TUBING NEAR THE MALE LUER LOCK WAS SEVERED. THERE WAS NO PATIENT OR MEDICAL INTERVENTION 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 BAXTER HEALTHCARE - MALTA 10K30V480D

    Patients

    Seq Age Sex Outcome Treatment
    1