BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMED POLYURETHANE FEEDING TUBE

    MDR report key: 1739650 · Received May 24, 2010

    Report

    Report Number
    3006520777-2010-00001
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 21, 2010
    Manufacturer
    NEOMED, INC.
    Product Code
    FPD
    PMA / PMN Number
    K082238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED 4 SEGMENTS FOR INVESTIGATION AND INITIALLY REPORTED TO FDA THAT THESE WERE "FOUR FRAGMENTS OF A DISTAL ILEAL FEEDING TUBE." REFER TO UF/IMPORTER REPORT # (B)(4) AS FORWARDED TO MANUFACTURER BY FDA. ACTUALLY, THREE OF THE FOUR SEGMENTS RETURNED CONTAIN SIDE HOLES, WHICH INDICATE THAT THESE ARE TIPS OF THREE FEEDING TUBES. THE FOURTH SEGMENT IS A MATCH TO ONE OF THE THREE FEEDING TUBES. THE RELATIONSHIP BETWEEN THE PRODUCT AND THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED DUE TO THE LIMITED AVAILABILITY OF INFO. INDICATIONS FOR USE ON CURRENT LABELING IS "TO PROVIDE NUTRITION VIA NASAL OR ORAL GASTRIC PLACEMENT." JEJUNAL PLACEMENT THROUGH A STOMA IS NOT A RECOMMENDATION ON THE CURRENT LABELING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BROKEN FEEDING TUBE IN THE PT. THE FEEDING TUBE WAS USED TO RE-INTRODUCE BILE AND FECAL MATTER VIA THE STOMA INTO THE INFANT. THE PT UNDERWENT A CLOSURE PROCEDURE FOR A JEJUNOSTOMY. FOUR SEGMENTS OF FEEDING TUBES WERE FOUND IN THE BOWEL ADJACENT TO THE STOMACH. THESE WERE RECOVERED FROM THE PT AND RETURNED TO MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMED POLYURETHANE FEEDING TUBE TUBE, FEEDING (POLYURETHANE) FPD NEOMED, INC. FTS8.0P-EO 08042009

    Patients

    Seq Age Sex Outcome Treatment
    1 37 DA Other