BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELEE W/VALVE 10FR MUCUS TRAP

    MDR report key: 23498944 · Received November 7, 2025

    Report

    Report Number
    MW5178663
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    February 23, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    BYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY FRIEND WORKS FOR A HOSPITAL WHO REPORTED THIS PROBLEM TO THE MANUFACTURER BUT THE MANUFACTURER STILL HAS NOT SUBMITTED THE REPORT TO THE FDA AND THE EVENT OCCURRED 8 MONTHS AGO. I BELIEVE THIS IS NOT ONLY REPORTABLE BUT IS A VERY SERIOUS ISSUE THAT NEEDS IMMEDIATE ATTENTION. THE SUCTION CATHETER (DELEE W/VALVE 10F) DID NOT WORK WHEN NEEDED FOR INFANT RESUSCITATION. MULTIPLE SUCTION CATHETERS HAVE TO BE USED WHEN THESE DON'T PROVIDE SUCTION. THIS IS NOT AN ISOLATED INCIDENT, AND THESE ARE USED ON INFANTS. IT HAPPENED SEVERAL TIMES WITH DIFFERENT LOTS AND WAS MENTIONED BY MULTIPLE NURSES. THE NURSE IS CONCERNED THAT THERE WILL BE ACTION AGAINST HER OR HER HOSPITAL IF SHE REPORTS DIRECTLY. I WAITED 8 MONTHS FOR THIS TO BE REPORTED AND IT IS STILL NOT IN PUBLIC MAUDE SO THIS IS WHY I'M REPORTING. IT IS VERY POSSIBLE THE DEVICE WAS RETURNED TO THE MANUFACTURER. THIS SUPPLY CHAIN NURSE SAID THAT THERE HAVE BEEN SO MANY MEDLINE RECALLS IN THE LAST YEAR (INDIVIDUAL DEVICES AND KITS) THAT THEY HAVE HAD TO HIRE ANOTHER PERSON JUST TO MANAGE THOSE RECALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228655 DELEE W/VALVE 10FR MUCUS TRAP TRAP, STERILE SPECIMEN BYZ MEDLINE INDUSTRIES, LP - NORTHFIELD 18322120001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L