BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 3150079 · Received March 20, 2013

    Report

    Report Number
    9616066-2013-00188
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED BREAK. ALTHOUGH REQUESTED, THE VALVE HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS, SHOULD THE DEVICE BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NEEDLELESS VALVE COVERING THE END OF THE CENTRAL LINE CATHETER BROKE. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116581 SMARTSITE NEEDLE-FREE VALVE FPA CAREFUSION CORPORATION 2000E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CENTRAL LINE CATHETER, MFR, MODEL, LOT UNKNOWN