BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPK CORFLO WITH STYLET

    MDR report key: 6323356 · Received February 10, 2017

    Report

    Report Number
    3009124963-2017-00002
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    November 18, 2016
    Report Date
    February 26, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ONE SAMPLE DEVICE WAS RETURNED. THE ORIGINAL PACKAGING WAS NOT RETURNED WITH THE DEVICE. THE RETURNED SAMPLE DEVICE WAS EXAMINED UNDER MAGNIFICATION (50X) IDENTIFYING THAT THE TUBING HAD SIGNS OF DAMAGE. THERE WAS AN EXTERNAL SPLIT/TEAR IDENTIFIED IN BETWEEN 70CM AND 80 CM APPROXIMATELY AT THE 74CM MARKING WHEN THE TUBING WAS FLUSHED WITH WATER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THE USER HAS BEEN USING THE DEVICE FOR MANY YEARS AND USED WATER EVERYTIME WHEN REMOVING THE GUIDE WIRE. DURING THIS EVENT IT WAS NOTED THAT AFTER THE PATIENT WENT HOME THE MEDICAL DEVICE WAS LEAKING. THE TUBING WAS REMOVED AND IT WAS NOTED THE DEVICE WAS DAMAGED. TWO TEARS APPROXIMATELY 0.75CM BELOW THE TIP OF THE TUBING WERE OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105950 CPK CORFLO WITH STYLET NG TUBE KNT HALYARD HEALTH 2227481 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1