BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 16156935 · Received January 13, 2023

    Report

    Report Number
    16156935
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 10, 2023
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    MLS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE SETTING UP A VAGINAL DELIVERY TABLE, THE NURSE NOTED THERE WERE ONLY 4 RFID SPONGES PRESENT IN THE PACK. SHE VERIFIED IT WITH ANOTHER REGISTERED NURSE, WHO ALSO ONLY COUNTED FOR RFID SPONGES. LOT NUMBER OF THE VAGINAL PACK (SMA7CVDYNH) IS LOT# 924086. THIS RN NOTIFIED MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075129 CARDINAL HEALTH LABOR AND DELIVERY KIT MLS CARDINAL HEALTH 200, LLC SMA7CVDYNH 924086

    Patients

    Seq Age Sex Outcome Treatment
    1 Female