BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 13117645 · Received December 30, 2021

    Report

    Report Number
    13117645
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    September 14, 2021
    Report Date
    December 8, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELIEF CIRCULATOR AND SURGICAL TECH WERE PERFORMING AN INITIAL COUNT FOR A HERNIA REPAIR WITH SMALL TAPES FROM HERNIA PROCEDURE PACK. THE SMALL TAPES CONTAINED 4 SMALL TAPES, NOT 5. THE SMALL TAPES WERE TAKEN OFF THE FIELD AND OUT OF THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018749 CARDINAL HEALTH GENERAL SURGERY TRAY (KIT) LRO CARDINAL HEALTH 200, LLC 620684

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other