BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE FREE VALVE

    MDR report key: 3820771 · Received April 30, 2014

    Report

    Report Number
    9616066-2014-00426
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    December 24, 2013
    Report Date
    April 2, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2014. INTERNAL FILE NO: (B)(4). UNABLE TO DETERMINE THE CAUSE OF CUSTOMER'S REPORTED DISCONNECTION FROM THE PICC LINE BECAUSE THE VALVE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD WAS FOUND ON THE PT'S BED. UPON INSPECTION, THE SMARTSITE VALVE WAS FOUND DISCONNECTED FROM THE RED PORT ON THE PICC LINE AND BLOOD WAS DRIPPING FROM THE PORT. THE VALVE WAS REPLACED. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259555 SMARTSITE NEEDLE FREE VALVE FPA CAREFUSION CORP 2000E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PICC LINE: MFR/MODEL/LOT UNK