BEUDAMED
    FDA Adverse Event Summary report: N

    SECURACATH

    MDR report key: 3622136 · Received December 3, 2013

    Report

    Report Number
    3622136
    Date Received
    December 3, 2013
    Date of Event
    November 15, 2013
    Report Date
    December 3, 2013
    Manufacturer
    INTERRAD MEDICAL INC
    Product Code
    OKC
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MULTIPLE ATTEMPTS WERE MADE TO DISCONTINUE A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE NURSE STATED THE PROBLEMATIC PIECE ON THE DEVICE WAS CUT IN TWO AS PER INSTRUCTIONS GIVEN BY THE MANUFACTURER REPRESENTATIVE. ONE HALF OF THE METAL PRONGS STAYED IMBEDDED INTO THE SKIN. IT WAS OBSERVED THE METAL PRONGS THAT SECURE THE DEVICE SUB-DERMALLY HAD IMBEDDED QUITE FIRMLY INTO SUB DERMAL TISSUE. EVERY FEASIBLE ANGLE WAS ATTEMPTED TO REMOVE THE DEVICE IN A GENTLE FASHION. THE NURSE SAID THE BEST WAY TO DESCRIBE THE PROCESS IS SIMILAR TO REMOVING AN IMPLANTED FISH HOOK FROM SKIN.THERE HAVE BEEN MULTIPLE COMPLAINTS FROM MANY STAFF REGARDING THIS PARTICULAR PICC REMOVAL. EXPERIENCED STAFF NURSES WERE HAVING DIFFICULTY. THE MANUFACTURER HAS SENT OUT REPRESENTATIVES FOR IN-SERVICES SINCE BUT THIS MAKES NO DIFFERENCE IN THE REMOVALS. STAFF HAS SAID THAT AT TIMES THERE IS 'TISSUE' ATTACHED TO THE METAL PRONGS ON REMOVAL. THE PATIENT STATE THE EXPERIENCE IS 'HORRIBLE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626775 SECURACATH CATHETER, INTRAVASCULAR CATHETER SECUREMENT OKC INTERRAD MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR