BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILDREN'S MEDICAL VENTURES

    MDR report key: 2659805 · Received July 11, 2012

    Report

    Report Number
    2659805
    Event Type
    Malfunction
    Date Received
    July 11, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 11, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE FILLING A NEWLY OPENED FEEDING SYRINGE WITH MILK FOR A PATIENT, I NOTICED THAT THERE WAS SOMETHING "DARK" ON THE INSIDE OF THE SYRINGE. UPON FURTHER INSPECTION, THE "OBJECT" WAS STUCK AND LOOKED SUSPICIOUS. I DISCARDED THE MILK FROM THE SYRINGE AND FISHED OUT A SMALL, COILED, PIECE OF METAL THAT WAS STUCK TO THE INSIDE OF THE SYRINGE. UNCERTAIN WHICH PACKAGE (LOT NUMBER) THE SYRINGE ACTUALLY CAME FROM AS I WAS FILLING 8 DIFFERENT SYRINGES. HOWEVER, LOT NUMBERS CAN BE NARROWED DOWN TO ONE OF THE FOLLOWING: 80413, 79735, 84283, 80287, OR 79460.THIS IS A STERILE SINGLE USE SYRINGE THAT COMES PACKAGED IN A STERILE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILDREN'S MEDICAL VENTURES SYRINGE, STERILE, FEEDING FPD PHILIPS MEDICAL SYSTEMS 1041084 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY