BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVITY SET

    MDR report key: 4230082 · Received October 24, 2014

    Report

    Report Number
    9616066-2014-01019
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K820278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED BY THE MFR. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKAGE AT THE DISTAL PORT WHERE THE SECONDARY ANTIBIOTICS HAD BEEN INFUSING. THERE WAS AIR IN THE LINE, BUT IT DID NOT REACH THE PT. THE TUBING WAS QUICKLY REMOVED AND REPLACED. NO PT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677954 GRAVITY SET IV INFUSION SET FPA CAREFUSION CORP DYNDTN1512 14055131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY TUBING: MFR/MODEL/LOT UNK