BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERAL SAFE FEEDING TUBE, 5 FR X 36" POLYURET

    MDR report key: 4201141 · Received September 16, 2014

    Report

    Report Number
    1060680-2014-00038
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 15, 2014
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    FPD
    PMA / PMN Number
    K100700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: (B)(4) HAS BEEN ISSUED TO THE VENDOR. ADD'L INFO HAS BEEN REQUESTED FROM THE DEROYAL SALES REP IN REFERENCE TO THE FAILURE REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. WILL PROVIDE FOLLOW UPS IF INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WORKED WELL INITIALLY, AT THE START OF THE FEEDING. THE ISSUE OCCURRED EACH TIME AT THE END OF THE FEEDING. WHERE THE CONNECTION BETWEEN THE EXTENSION SET AND FEEDING TUBE WOULD BE DISCONNECTED OR LOOSEN BASED OFF "A PUSH BACK" FROM THE FORMULA. IT SEEMS AS THE FEEDING CONTINUED, THE FEEDING TUBE WOULD BECOME OCCLUDED OR BLOCKED, CAUSING A BUILD UP OF PRESSURE TO LOOSEN THE CONNECTION, THEREFORE, RESULTING IN A LEAK OR "APRIL" AT THE CONNECTION POINT. THE ISSUE WAS IDENTIFIED DURING ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572383 ENTERAL SAFE FEEDING TUBE, 5 FR X 36" POLYURET TUBE, FEEDING FPD DEROYAL INDUSTRIES 089172

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention