BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOME DEFINED PRODUCT

    MDR report key: 3884148 · Received June 19, 2014

    Report

    Report Number
    2015691-2014-01409
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE RETURN OF THE ACTUAL COMPLAINT UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTATE MALE CONNECTOR FOR THE PEDIATRIC AND BD INSYTE AUTOGUARD CATHETER COULD NOT BE CONNECTED WELL AND GOT DETACHED DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361361 CUSTOME DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR VP13B6TSPL

    Patients

    Seq Age Sex Outcome Treatment
    1