BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARYGLE TURKEL SAFETY THORACENTESIS PROCEDURE TRAY

    MDR report key: 279894 · Received May 24, 2000

    Report

    Report Number
    9610849-2000-00017
    Event Type
    Malfunction
    Date Received
    May 24, 2000
    Date of Event
    April 24, 2000
    Report Date
    May 23, 2000
    Manufacturer
    THE KENDALL CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    KENDALL HEALTH CARE RECEIVED PHONE CALL ON 4/24/00 CONCERNING AIR LEAKS FOUND IN THE BALL/ VALVE ASSEMBLY WITHIN THE THORACENTESIS CATHETERS. MD REPORTS THAT DURING PROCEDURES DR HAS HEARD AIR LEAKS, HOWEVER, MD REPORTS THAT WHEN MD WITHDREW THE TURKEL NEEDLE FROM THE CATHETER DURING THE LAST PROCEDURE MD WITNESSED AIR BUBBLES IN THE LINE AND WAS CONCERNED THAT AIR WAS BEING INTRODUCED INTO THE PLEURAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARYGLE TURKEL SAFETY THORACENTESIS PROCEDURE TRAY THORACENTESIS CATHETER KDQ THE KENDALL CO. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other