BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORFLO ULTRA NG 8FR (WITH 3GM WEIGHT)

    MDR report key: 2923253 · Received January 8, 2013

    Report

    Report Number
    3009124963-2012-00036
    Event Type
    Other
    Date Received
    January 8, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 4, 2013
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    FPD
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED. THE RETURNED DEVICE WAS VISUALLY EXAMINED AND FOUND TO HAVE BROKEN OR TORN AT THE BOLUS (NEAR THE END OF THE FEEDING TUBE). RETENTION SAMPLES FROM SIMILAR PRODUCTS HAVE BEEN TESTED IN ORDER TO DUPLICATE A SIMILAR BREAK. MORE THAN 5 LBS OF TENSILE FORCE WAS APPLIED TO BE FEEDING TUBE. IT IS UNCLEAR HOW THESE TYPES OF FORCEPS COULD BE APPLIED TO THE TUBE DURING CLINICAL USE.

    Description of Event or Problem · 1

    THE TUBE TIP CAME OFF THE TUBE. NO OTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10059 CORFLO ULTRA NG 8FR (WITH 3GM WEIGHT) FEEDING TUBE (NASOGASTRIC TUBE) FPD CORPAK MEDSYSTEMS 20-7438 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other