BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL ENTERAL SYRINGE

    MDR report key: 2720284 · Received August 22, 2012

    Report

    Report Number
    2720284
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 22, 2012
    Manufacturer
    PHILIPS CHILDRENS MEDICAL VENTURES
    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

    SHARP PLASTIC SHARD FOUND IN 60CC FEEDING SYRINGE, NOTICED IMMEDIATELY AND WAS NOT GIVEN TO PATIENT. LOT # 85310.======================MANUFACTURER RESPONSE FOR 60 ML ORAL SYRINGE, 60 ML ORAL SYRINGE (PER SITE REPORTER).======================WILL EVALUATE WHEN PRODUCT IS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL ENTERAL SYRINGE TUBE, FEEDING FPD PHILIPS CHILDRENS MEDICAL VENTURES * 85310

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY