BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F COAXIAL MICROINTRODUCER KIT

    MDR report key: 3770429 · Received February 18, 2014

    Report

    Report Number
    3006260740-2014-00052
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 23, 2014
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    DYB
    PMA / PMN Number
    K990705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF ASXHE001 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    AFTER THEY ADVANCED THE GUIDEWIRE OF A PORT A CATH, IT APPEARED THAT IT WAS IN THE PT. THE WIRE UNCOILED BUT SHE WASN'T SURE WHEN IT UNCOILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102601 5F COAXIAL MICROINTRODUCER KIT DYB C.R. BARD, INC (BASD) ASXHE001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention