BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY STERILE CONTAINER

    MDR report key: 4103284 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32435
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED ISSUE. A VISUAL INSPECTION WAS PERFORMED WITH AND A HOLE WAS IDENTIFIED ON THE MATTE AND SHINY SIDE THE BAG AND EXCESS SOLVENT ON THE MOLDED PORT. A LEAK TEST WAS PERFORMED WITH UNDERWATER PRESSURE TESTING WITH A LEAK NOTED FROM A HOLE IN THE BAG. THE VISUAL AND FUNCTIONAL INSPECTION RESULTS IDENTIFIED THE SAMPLE FAILED TO MEET PRODUCT SPECIFICATIONS. A BATCH REVIEW WAS CONDUCTED ON LOT NUMBER H13L03054 AND THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3 LITER EMPTY STERILE CONTAINER HAD A HOLE. THE LOCATION OF THE HOLE WAS DESCRIBED AS BEING ¿WHERE THE PORT WAS IN CONTACT WITH THE BAG¿. THIS WAS NOTICED AS THE BAG WAS BEING REMOVED FROM THE OVERPOUCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582615 EMPTY STERILE CONTAINER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H13L03054

    Patients

    Seq Age Sex Outcome Treatment
    1