BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVON

    MDR report key: 17597 · Received August 2, 1994

    Report

    Report Number
    17597
    Event Type
    Malfunction
    Date Received
    August 2, 1994
    Date of Event
    April 13, 1994
    Report Date
    April 25, 1994
    Manufacturer
    DEVON INDUSTRIES
    Product Code
    GDJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON APRIL 8, 1994, WHILE USING A TUBE OCCLUDING PLASTIC CLAMP IN THE DIALYSIS UNIT, THE TIP SNAPPED OFF. THERE WAS NO DISTRIBUTION MANAGER NOTIFIED MANUFACTURER OF THE PROBLEM ON APRIL 8, RECEIVED COMPLAINTS FROM OTHER INSTITUTIONS, AND WAS IN THE PROCESS OF CHANGING MANUFACTURERS. MANUFACTURER REPLACED ALL OF THE EXISTING SHELF AND EXCHANGE CART STOCK. HOWEVER, THERE WAS STILL STOCK LEFT IN PATIENT ROOMS THAT WAS NOT REMOVED. ON APRIL 13, 1994, A CLAMP BROKE AT THE TIP DURING REPAIR OF A CENTRAL LINE ON A ATIENT RECEIVING CHEMOTHERAPY WITH A CENTRAL VENOUS LINE ALLOWING ESCAPE OF BLOOD. THERE WAS ALSO A TOTENTIAL FOR CONTAMINATION OF AIR IN THELINE, ALTHOUGH NO AIR ENTRY OCCURRED.THE HOSPITAL HAS INSTITUTED AN IN-HOUSE RECALL OF ALL TUBE OCCLUDING PLASTIC CLAMPS FROM THIS MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVON TUBE OCCLUDING PLASTIC CLAMP GDJ DEVON INDUSTRIES 727 40461

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other