BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 2903593 · Received January 4, 2013

    Report

    Report Number
    9616066-2012-00928
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 6, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ADMINISTRATION SET WAS ATTACHED TO A SMARTSITE VALVE WHICH WAS ATTACHED TO THE PICC LINE. WHEN THE SET WAS DISCONNECTED FROM THE SMARTSITE VALVE ON THE PICC LINE, THE OPAQUE PART OF THE SMARTSITE VALVE SNAPPED APART. THE USER WAS UNABLE TO REMOVE THE REMAINING PORTION OF THE SMARTSITE VALVE (MALE LUER) FROM THE PICC LINE AND THE PICC LINE HAD TO BE REPLACED. NO LONG TERM PATIENT HARM WAS REPORTED AND NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5288 SMARTSITE NEEDLE-FREE VALVE FPA CAREFUSION CORP. 2000E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PERIPHERALLY INSERTED CENTRAL CATHETER| LOT # UNK, THERAPY DATE UNK| MANUFACTURER, MODEL/LOT #UNK, THERAPY DATE UNK| ALARIS SE ADMINISTRATION SET, MODEL 72023E