BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVITY INFUSION SET

    MDR report key: 1892565 · Received November 3, 2010

    Report

    Report Number
    9616066-2010-00314
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 23, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K820278
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S EXPERIENCE WAS CONFIRMED. THE DISCONNECTION OCCURRED BECAUSE THE FLA HAD NOT BEEN WELDED TO THE CLEAR CASING. THIS APPEARS TO HAVE BEEN CAUSED BY THE FLA BEING DEFORMED OR DAMAGED AFTER THE MOULDING PROCESS AND PRIOR TO THE ASSEMBLY PROCESS. THIS MEANS THAT THE FLA WAS NOT COMPLETELY PUSHED ONTO THE CLEAR CASING PRIOR TO THE WELDING PROCESS. A REVIEW OF THE PRODUCTION RECORDS FOR (B)(4), LOT NUMBER 09065168 SHOWED THAT NO QUALITY NOTIFICATIONS WERE RAISED FOR FAILURES OR QUALITY DEVIATIONS DURING MFG.

    Description of Event or Problem · 1

    THE USER REPORTED THAT WHEN THEY ATTEMPTED TO REMOVE THE SYRINGE FROM THE SMARTSITE FOLLOWING A BOLUS FROM THE UPPER PORT, THE FEMALE LUER ADAPTOR (FLA) DISCONNECTED FROM THE CLEAR CASTING OF THE SMARTSITE. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAVITY INFUSION SET FPA CAREFUSION CORPORATION 42293E 09065168

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK