BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT 3-SPIKE DISPOSABLE SET

    MDR report key: 7940683 · Received October 5, 2018

    Report

    Report Number
    1219702-2018-00036
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    August 17, 2018
    Report Date
    October 5, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    UDI-DI
    00896128002022
    PMA / PMN Number
    K141654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO CONFIRM THE CUSTOMER COMPLAINT REGARDING A LEAK, AS THE 3-SPIKE DISPOSABLE SET WAS DISCARDED AT THE HOSPITAL AND UNABLE TO BE RETURNED FOR INVESTIGATION. THE MANUFACTURING RECORDS OF THE ASSOCIATED LOT WERE REVIEWED; NOTHING NOTABLE WAS OBSERVED. ALL 3-SPIKE DISPOSABLE SETS MANUFACTURED ARE 100% LEAK TESTED PRIOR TO RELEASE. THE RETENTION SAMPLE WAS TESTED AND NO LEAKS WERE OBSERVED. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    ON SEPTEMBER 10, 2018, THE BELMONT SALES REPRESENTATIVE RECEIVED A CALL FROM THE CLINICAL EDUCATOR AT THE USER FACILITY, STATING THAT THE STAFF NOTICED A LEAK COMING FROM THE TOP OF THE 3-SPIKE DISPOSABLE SET WHILE THE BELMONT RAPID INFUSER WAS IN USE. THE TUBING WAS REPLACED AND THE IMPLICATED DISPOSABLE SET WAS SUBSEQUENTLY DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781556 THE BELMONT 3-SPIKE DISPOSABLE SET THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT LLC 3-SPIKE DISPOSABLE SET 2018-04 02 00896128002022

    Patients

    Seq Age Sex Outcome Treatment
    1