BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPK CORFLO WITH STYLET

    MDR report key: 6330596 · Received February 14, 2017

    Report

    Report Number
    3009124963-2017-00003
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Report Date
    January 18, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, 72678, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ONE SAMPLE DEVICE WAS RETURNED. THE ORIGINAL PACKAGING WAS NOT RETURNED WITH THE DEVICE. THE SAMPLE WAS ALSO RETURNED WITH A STYLET. THE RETURNED SAMPLE DEVICE WAS INFUSED WITH WATER TO SHOW A FLUID PATHWAY. THERE WAS LEAKAGE SEEN APPROXIMATELY IN THE 80.5 CM. THE TUBE WAS EXAMINED UNDER MAGNIFICATION (50X), THERE WAS SLIT/HOLE APPEARANCES IDENTIFIED. A RED ARROW WAS USED TO SHOW THE LOCATION OF THE DEFECT. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING LEAKAGE WAS CONFIRMED WHEN FLUSHING THE WATER AND A TEAR WAS OBSERVED ON THE NASOGASTRIC TUBE (NGT). UPON FURTHER REVIEW A TEAR WAS OBSERVED AT THE MARKING OF 80CM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111653 CPK CORFLO WITH STYLET DH CPK NG TUBES KNT HALYARD HEALTH EDA7482 72678

    Patients

    Seq Age Sex Outcome Treatment
    1