BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH GENERAL ENDO OSC PACK

    MDR report key: 10808603 · Received November 9, 2020

    Report

    Report Number
    10808603
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 3, 2020
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO STAFF PERSONNEL, DURING THE SET UP FOR A PEDIATRIC LAPAROSCOPIC GASTROTOMY TUBE PLACEMENT THE PACK FOR THE BACK TABLE WAS THE ONLY ITEM OPEN AT THE TIME. THE SURGICAL TECH STUDENT WAS ORGANIZING THE SUPPLIES ON THE BACK TABLE, UNDER THE SUPERVISION OF HIS/HER PRECEPTOR AND FOUND A FORCEP LOCATED IN A BLUE BOWL IN THE PACK. SINCE THERE WERE NO OTHER SUPPLIES OPENED AT THIS TIME, IT WAS CONCLUDED THAT THE FORCEP CAME FROM THE STERILE PACK. WE CALLED OUR SUPERVISOR TO FIND OUT THE COURSE OF ACTION AND WERE TOLD TO TAKE IT ALL DOWN AND START OVER. LACKING PROPER STERILIZATION PARAMETERS, WE COULD NOT CONFIRM THAT THE FORCEP WAS TRULY STERILE. THIS ALL TOOK PLACE BEFORE THE PATIENT ARRIVED AT THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277212 CARDINAL HEALTH GENERAL ENDO OSC PACK ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC 483530

    Patients

    Seq Age Sex Outcome Treatment
    1 56 DA