BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3983709 · Received June 25, 2014

    Report

    Report Number
    9616066-2014-00638
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: JUNE 25, 2014. (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILST THEY WERE CHANGING THE EXTENSION SET CONNECTED TO THE PICC LINE, THE MALE LUER LOCK BROKE. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371053 SMARTSITE EXTENSION SET EXTENSION SET FPA CAREFUSION CORPORATION 20039E7D 13105142

    Patients

    Seq Age Sex Outcome Treatment
    1 PICC LINE MANUFACTURER/MODEL/LOT UNKNOWN