BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2873768 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07349
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AN ACTUAL SAMPLE WAS AVAILABLE FOR EVALUATION. THE VIALMATE ARRIVED ATTACHED TO A VIAL AND A VIAFLO BAG. THE VIALMATE WAS UNLOCKED. VISUAL INSPECTION ON THE SAMPLE REVEALED A TINY PART OF THE VIAL'S RUBBER IN THE VIAL. INSPECTION ON THE VIAL'S MEMBRANE SHOWED THAT PIERCING WAS NOT CENTRED BUT HAS BEEN DONE AT AN ANGLE. VIALMATE WAS DISMANTLED TO BE FURTHER INVESTIGATED, HOWEVER THE VIALMATE SHOWED NO NON-CONFORMITIES. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A MISUE OF PRODUCT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A LABELING REVIEW WAS PERFORMED AND THE INSTRUCTIONS ARE PRINTED ON EACH INDIVIDUAL PACKAGING ARE AVAILABLE TO THE USER AND ARE ACCURATE AND SUFFICIENT. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER.

    Description of Event or Problem · 1

    (B)(4). UPON VISUAL INSPECTION, THE SAMPLE REVEALED A TINY PART OF THE VIAL'S RUBBER IN THE VIAL. INSPECTION ON THE VIAL'S MEMBRANE SHOWED THAT THE PIERCING WAS NOT CENTERED BUT HAS BEEN DONE AT AN ANGLE. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - MALTA 12G27V182

    Patients

    Seq Age Sex Outcome Treatment
    1