BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1982955 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00800
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE AND 2 COMPANION SAMPLES WERE SUBMITTED FOR EVALUATION. HOWEVER, ONLY THE ACTUAL SAMPLE WAS EVALUATED. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE REPORTED CONDITION OF A DAMAGED SPIKE. FROM SAMPLE INVESTIGATIONS IT CAN BE DETERMINED THAT THE SPIKE BROKE WHILST INTRODUCING THE SPIKE INTO THE BAG/BOTTLE SINCE SOLUTION WAS NOTICED IN THE TUBING. THIS IMPLICATES THAT THE SET GOT DAMAGED DURING THE INSERTION OF THE SPIKE IN THE INFUSION BAG. THE CHAMBERS USED WITH THIS SET ARE PURCHASED FROM AN EXTERNAL SUPPLIER. A SUPPLIER VISIT HAS ALREADY BEEN PERFORMED TO INVESTIGATE FURTHER THIS ISSUE. A SUPPLIER CORRECTIVE ACTION REPORT HAS BEEN OPENED AND FURTHER INVESTIGATIONS ARE ON GOING TO DETERMINE ANY ACTION/S TO STRENGTHEN THE SPIKE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. THE PRODUCT CODE OF THIS DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT HAVE A US 510K NUMBER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A ADMINISTRATION SET WITH A DAMAGED SPIKE. THIS REPORTED CONDITION OCCURRED DURING SETUP. NO CLINICAL CONSEQUENCES WERE REPORTED. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1