BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 3043167 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00172
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 21, 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 REPORTED BREAK. ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH RESULTS OF THE EVAL SHOULD THE DEVICE BE RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SMARTSITE VALVE ON THE CENTRAL LINE BROKE WHILE ATTEMPTING TO FLUSH THE LINE. THE CENTRAL LINE WAS CLAMPED IMMEDIATELY, THE SMARTSITE VALVE WAS REPLACED WITHOUT INCIDENT. THERE WAS NO PT HARM REPORTED. MEDICAL INTERVENTION WAS NOT REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106227 SMARTSITE NEEDLE-FREE VALVE FPA CAREFUSION CORPORATION 2000E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CENTRAL LINE, MFR/MODEL#/LOT# UNK| SYRINGE, MFR/MODEL#/LOT# UNK