BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANGAROO JOEY,PUMP W/POLE CLMP

    MDR report key: 6216734 · Received December 30, 2016

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    Report

    Report Number
    1282497-2016-01116
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    November 30, 2016
    Report Date
    October 23, 2017
    Manufacturer
    JABIL SINGAPORE
    Product Code
    LZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE UNIT HAS NOT BEEN RECEIVED FOR EVALUATION. WITHOUT THE UNIT, A DETAILED INVESTIGATION COULD NOT BE PERFORMED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THIS COMPLAINT FILE SHALL BE CLOSED AS UNCONFIRMED AT THIS TIME. IF THE UNIT IS RETURNED, THE COMPLAINT SHALL BE RE-OPENED. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A ROUTINE BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING PUMP. THE CUSTOMER STATES THERE WAS AN OCCLUSION AND THE ALARM DID NOT FUNCTION. THE PATIENT ALSO RESULTED IN HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866692 KANGAROO JOEY,PUMP W/POLE CLMP FEEDING PUMP LZH JABIL SINGAPORE 383400 B1500640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other