BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10FR CORFLO ULTRA NASOGASTRIC TUBE

    MDR report key: 3820763 · Received April 29, 2014

    Report

    Report Number
    3009124963-2014-00014
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY WAS REPORTED. THE RETURNED DEVICE WAS VISUALLY EXAMINED AND FOUND TO BE BROKEN OR TORN AT THE BOLUS NEAR THE END OF THE FEEDING TUBE. SIMILAR PRODUCT HAS BEEN MECHANICALLY TESTED AND IN ORDER TO DUPLICATE A SIMILAR BREAK MORE THAN 7 LBS OF TENSILE FORCE WAS APPLIED TO THE FEEDING TUBE. IT IS UNCLEAR HOW THESE TYPES OF FORCES COULD BE APPLIED TO THE TUBE DURING CLINICAL USE.

    Description of Event or Problem · 1

    THE FEEDING TUBE WAS PLACED ON (B)(6) 2013. WHEN THE PHYSICIAN REPLACED THE FEEDING TUBE WITH A NEW ONE ON (B)(6) 2014, HE NOTICED THE BOLUS TIP HAD SEPARATED FROM THE TUBE. THE WEIGHTED END REMAINED IN THE PATIENT'S BODY AS CONFIRMED BY X-RAY. ON (B)(6) AN ATTEMPT WAS MADE TO REMOVE THE BOLUS END ENDOSCOPICALLY BUT FAILED. THE WEIGHTED END WAS IN THE SIGMOID COLON. ON (B)(6) (B)(6) INFORMED US THAT THE WEIGHTED END HAD BEEN REMOVED ENDOSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256483 10FR CORFLO ULTRA NASOGASTRIC TUBE FEEDING TUBE KNT CORPAK MEDSYSTEMS 2227481 61837

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK