BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW-CLARKE

    MDR report key: 1002168 · Received January 29, 2008

    Report

    Report Number
    1002168
    Event Type
    Malfunction
    Date Received
    January 29, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 29, 2008
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CHECK OF A PLEURA-SEAL THORENCENTESIS DEVICE THE PLASTIC END SHEERED WHEN THE PROVIDER CHECKED THE CATHETER'S ABILITY TO RELEASE FROM THE NEEDLE. THE DEVICE WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW-CLARKE KIT, THORACENTESIS KDQ ARROW INTERNATIONAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *