BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2894430 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00131
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE SAMPLE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED. ONE OF THE SEAMS OF THE OVERPOUCH WAS OPENED BUT THERE WAS NO DAMAGE TO THE BAG INSIDE. NO FUNCTIONAL TESTS WERE PERFORMED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A 1L SOLUTION BAG IN WHICH "THE PRODUCT HAS PHYSICAL DAMAGE, BREAKAGE AND SCRATCHES EVIDENT ON THE PRODUCT BY ITSELF FOR HANDLING AND STORAGE. THIS FLAW WAS FOUND IN THE TIME OF USE BUT HAVE NOT REACHED THE INTERVENTION OF ANY PATIENT." THE PROCESS STEP WAS BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2948 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - CALI SX09HF9

    Patients

    Seq Age Sex Outcome Treatment
    1