BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESHIELD DUAL INJECTION SITE SEVICE

    MDR report key: 284148 · Received June 26, 2000

    Report

    Report Number
    1018381-2000-00032
    Event Type
    Other
    Date Received
    June 26, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 25, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D OF LEAKAGE OF SOLUTION FROM THE INJECTION PORT AROUND THE NEEDLE ENTRY POINT. CUSTOMER STATES THAT THEY "FREQUENTLY" HAVE PROBLEMS IN THE NUCLEAR CARDIOLOGY DEPARTMENT WITH INJECTION OF RADIOACTIVE ISOTOPE MATERIALS SUCH AS THALLIUM. THROUGHOUT THE SLOW PUSH INJECTION. THERE IS LEAKING OF THE MATERIAL FROM AROUND THE NEEDLE. THE LEAKAGE FALLS ON LINENS WHICH ARE APPROPRIATELY TAKEN CARE OF PER PROTOCOL. THE INJECTION PORTS HAVE NOT BEEN PUNCTURED PRIOR TO THE PROCEDURE. THERE HAS BEEN NO EXPOSURE WITH THE SOLUTIONS TO A PT OR EMPLOYEE, HOWEVER, THE CUSTOMER IS CONCERNED ABOUT THE POTENTIAL FOR EXPOSURE. THE NUCLEAR MEDICINE DEPARTMENTS USE SHARP 20 GAUGE NEEDLES FOR INJECTION AND INSERT DIRECTLY INTO THE CENTER OF THE TARGET ON THE PORT. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD DUAL INJECTION SITE SEVICE CATHETER GCE ABBOTT LABORATORIES NA 60155HG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other