BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 16276999 · Received February 1, 2023

    Report

    Report Number
    16276999
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 17, 2023
    Report Date
    January 20, 2023
    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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NARRATIVE FROM STAFF: DURING THE SETUP OF A ROBOTICALLY ASSISTED HERNIA REPAIR WHERE THE TWO RNS IN THE ROOM REALIZED THAT THE PACK USED TO PROVIDE A STERILE PACK TABLE AND ALSO COMES WITH A MAJORITY OF THE STERILE DISPOSABLE SUPPLIES FOR THE CASE HAS A LARGE TEAR DOWN THE MIDDLE. THEY IMMEDIATELY BROKE THE SETUP DOWN AND BEGAN RE-SETTING UP THE CASE. THERE WAS NO DELAY IN PATIENT CARE BUT THAT WAS ONLY BECAUSE OF THE HARD WORK AND COMMUNICATION OF THE TEAM IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732850 CARDINAL HEALTH ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC SBA13LCEMD 947013

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA Male