BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 8091903 · Received November 20, 2018

    Report

    Report Number
    3007795799-2018-00003
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 19, 2018
    Manufacturer
    INTERRAD MEDICAL
    Product Code
    OKC
    PMA / PMN Number
    K180769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A 5F TRIPLE LUMEN BARD POWERPICC HF SPLIT AND LEAKED THAT WAS BEING SECURED WITH A SECURACATH DEVICE. "PICC PLACE UNDER NORMAL CONDITIONS, 5FR SECURACATH WAS USED. IV CONTRAST WAS INJECTED THROUGH LINE ON (B)(6) 2011 . NO WAY OF KNOWING WHICH LUMEN WAS USED. RED LUMEN ONLY ONE POWER INJECTABLE. LINE DAMAGE NOT IDENTIFIED UNTIL LINE WAS REMOVED. THE SLIT IN THE WHITE LUMEN WAS BETWEEN THE 3 AND 4CM MARK. NURSE REMOVING LINE THOUGHT THE SECURACATH WAS ACTUALLY COVERING THE SLIT/HOLE. NO INDICATIONS OF LEAKING PRIOR TO PLANNED REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930209 SECURACATH SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE OKC INTERRAD MEDICAL SCR-01

    Patients

    Seq Age Sex Outcome Treatment
    1