BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 10378360 · Received August 7, 2020

    Report

    Report Number
    10378360
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 28, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND LAID SUPINE ON THE OPERATING TABLE. AFTER ADEQUATE GENERAL ANESTHESIA WAS OBTAINED, THE RIGHT SHOULDER WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A SMALL INCISION WAS MADE AND A LARGE AMOUNT OF PURULENT MATERIAL WAS THEN EVACUATED. THERE DOES APPEAR TO BE EXTENSION DOWN TO THE SHOULDER JOINT JUST ON MANUAL PALPATION WITH THE SUCTION DEVICE. FLUID WAS SENT FOR CULTURE. AT THIS POINT, THE PATIENT WENT INTO CARDIAC ARREST WITH VENTRICULAR FIBRILLATION. ACLS PROTOCOL WAS INITIATED WITH EVENTUAL RETURN OF SPONTANEOUS PULSES AS WELL AS RESPIRATIONS; HOWEVER, I DID NOT PLACE A DRAIN. I MERELY QUICKLY CLOSED THE SMALL INCISION DUE TO THE ONGOING NEED FOR CHEST COMPRESSIONS AND RESUSCITATION. THE PATIENT WAS TAKEN TO THE ICU IN CRITICAL CONDITION. DURING THE RESUSCITATION OF THE PATIENT ON THE AFOREMENTIONED INCIDENT, THE B.BRAUN MEDICAL INC. INTROCAN FEP STRAIGHT SAFETY® IV CATHETER 14 GA. X 1.25 IN. BROKE INSIDE THE PATIENT'S AV FISTULA WHERE THE HUB MEETS THE CATHETER SHAFT. THE BROKEN END WAS NOT RETRIEVED AT THE TIME DUE TO THE PATIENT'S CRITICAL CONDITION. IT IS PRESUMED THAT IT MIGRATED TO THE PULMONARY VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842239 INTROCAN SAFETY INTRODUCER, CATHETER DYB B. BRAUN MEDICAL INC. 4251890-02

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA Other