BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VESSEL LOOP, RED, MAXI, NON-STERILE

    MDR report key: 3223815 · Received July 2, 2013

    Report

    Report Number
    1836161-2013-00129
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    KDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED: THE TUBING IS EXTREMELY THIN AND STRETCHES WHEN USED. THE MAIN FUNCTION OF THIS IS, AS A TOURNIQUET AROUND A BLOOD VESSEL (ARTERY, VENA CAVA) IN ORDER TO LIMIT FLOW THROUGH THAT VESSEL SO THAT THE PROCEDURE CAN BE ACCOMPLISHED. THIS PRODUCT WAS USED DURING A DOUBLE VENOUS CANNULATION AND THE LOOP STRETCHED TO THE POINT THAT THE VENA CAVA COULD NOT BE OCCLUDED AROUND THE CANNULA. THIS CAN HAVE CATASTROPHIC EFFECTS. CUSTOMER REQUESTED THAT THESE BE REMOVED FROM THE SHELF AND REPLACED FROM PRIOR PRODUCT FROM ANOTHER SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300552 VESSEL LOOP, RED, MAXI, NON-STERILE VESSEL LOOPS KDC ASPEN SURGICAL PRODUCTS, INC. 011011NBG 5474-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1