BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE HYSTEROSCOPY D AND C PACK

    MDR report key: 16514175 · Received March 8, 2023

    Report

    Report Number
    MW5115615
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 7, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO HYSTEROSCOPY DILATION AND CURETTAGE PACKS BOTH HAD HOLES IN THE TABLE COVER DRAPE. THE PACKS WERE OPENED PREOPERATIVELY, CAUSING NO PATIENT HARM. WHILE TEAM MEMBERS WERE OPENING THE PACKS (THE FIRST STEP TO SETTING UP A STERILE TABLE) IS WHEN THEY NOTICED THE HOLE IN THE DRAPE. DRAPE WAS REMOVED AND NEW PACK OPENED WITH HOLES FOUND AGAIN IN TABLE COVER DRAPE. THIS DRAPE WAS ALSO REMOVED FROM AREA. REFERENCE REPORT: MW5115616.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593032 MEDLINE HYSTEROSCOPY D AND C PACK HYSTERECTOMY KIT OJF MEDLINE INDUSTRIES, INC. DYNJ51741B (10)22GBS353

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other