BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAL/ENTERAL SYRINGE

    MDR report key: 2020289 · Received March 11, 2011

    Report

    Report Number
    3007056120-2011-00005
    Event Type
    Other
    Date Received
    March 11, 2011
    Date of Event
    January 24, 2011
    Report Date
    March 4, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    KYX
    PMA / PMN Number
    K100099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING A THIN LAYER OF A GREEN TINTED SUBSTANCE WAS PRESENT WITHIN A 60ML ORAL/ENTERAL SYRINGE. THE SYRINGE WAS NOT PLACED INTO PT USE AND THERE WAS NO PT HARM OR INJURY. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS ISSUE AND WILL FILE A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL/ENTERAL SYRINGE 60ML, 1PC ORANGE ORAL SYRINGE; STERILE KYX PHILIPS RESPIRONICS, INC. 1062683 20101001

    Patients

    Seq Age Sex Outcome Treatment
    1