BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFELINE INJECTION CAP

    MDR report key: 34239 · Received July 18, 1996

    Report

    Report Number
    MW1009514
    Event Type
    Injury
    Date Received
    July 18, 1996
    Date of Event
    July 8, 1996
    Report Date
    July 15, 1996
    Manufacturer
    MC GAW,INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RUBBER SEPTUM OF THE INJECTION CAP BECAME DISLODGED AND WAS NO LONGER OCCLUDING THE CAP CAUSING THE SYSTEM TO BE OPEN. THE CAP WAS AT THE DISTAL END OF A HUBER NEEDLE EXTENSION TUBE THAT WAS ACCESSED INTO A CLIENT'S CATHETER. THE PT HAD A BLOOD BACK UP AND ACTUALLY BLED OUT OF THE NON-OCCLUDED INJECTION CAP. PT DID CALL THE OFFICE, THE TUBING WAS CLAMPED, BLEEDING STOPPED AND THE RN REPLACED THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFELINE INJECTION CAP CATHETER PORT CLOSURE FOZ MC GAW,INC. J6B119

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention