BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER KIT WITH INTEGRAL HEMOSTASIS

    MDR report key: 3792042 · Received April 17, 2014

    Report

    Report Number
    3792042
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ARROW INTERNATIONAL, INC.(SUBSIDIARY OF TELEFLEX, INC.)
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INTRODUCER KIT WAS MISSING A DILATOR WHEN THE KIT WAS OPENED FOR PLACEMENT. ANOTHER KIT WAS OPENED TO OBTAIN THE DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235509 PERCUTANEOUS SHEATH INTRODUCER KIT WITH INTEGRAL HEMOSTASIS INTRODUCER, CATHETER DYB ARROW INTERNATIONAL, INC.(SUBSIDIARY OF TELEFLEX, INC.) MZ-09883-S RF2109029

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR DIALYSIS| OTHER| LONG-TERM ANTIBIOTICS