BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

    MDR report key: 11567759 · Received March 25, 2021

    Report

    Report Number
    11567759
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    January 19, 2021
    Report Date
    March 16, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY USING A LAPAROSCOPIC PORT, WHILE IT WAS BEING PULLED THROUGH THE DEVICE BY THE DOCTOR AS HE WAS ATTEMPTING TO PLACE A MEDLINE 15 FRENCH ROUND DRAIN AND IT BROKE INTO SECTIONS- REF DYNJWE1323A, LOT P202221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465173 APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY MEDLINE INDUSTRIES, INC P202221

    Patients

    Seq Age Sex Outcome Treatment
    1