BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60'ENTERAL SET WITH ORAL SYRINGE ADAPTER

    MDR report key: 1909567 · Received November 19, 2010

    Report

    Report Number
    1909567
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS INC./ VYGON CORP
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LEAKS ARE OCCURRING AT THE DISTAL END WHERE THE SYRINGE IS ATTACHED TO THE TUBING. THREE SEPARATE TUBING SETS HAD LEAKS IN SAME LOCATION. ALL WERE FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60'ENTERAL SET WITH ORAL SYRINGE ADAPTER NEONATAL ENTERAL FEEDING TUBE FPD CHURCHILL MEDICAL SYSTEMS INC./ VYGON CORP AMS-934-1 1006193

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA