BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DH CPK NG TUBES

    MDR report key: 7628725 · Received June 22, 2018

    Report

    Report Number
    9611594-2018-00075
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 23, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 19-JUN-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. 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

    IT WAS REPORTED VIA MEDWATCH REPORT MW5077037 THAT A PATIENT HAD A NASOGASTRIC (NG) TUBE PLACED VIA THE CORTRAK SYSTEM AT ANOTHER HOSPITAL. THE PLACEMENT WAS VERIFIED VIA ABDOMINAL X-RAY. TUBE FEEDING BEGAN, BUT THE PATIENT DECOMPENSATED OVER A PERIOD OF 2 DAYS. CT SCAN SHOWED THE FEEDING TUBE WAS LOCATED IN THE PATIENT'S PERITONEAL SPACE. THE PATIENT TRANSFERRED HOSPITAL'S FOR A HIGHER LEVEL OF CARE, WAS TAKEN TO THE OPERATING ROOM, AND WAS FOUND TO HAVE A PERFORATION IN THE POSTERIOR NASOPHARYNX. THE TUBE WAS PASSED ALONGSIDE THE ESOPHAGUS, THROUGH THE MEDIASTINUM, THROUGH THE DIAPHRAGM AND INTO THE INTO THE PERITONEAL SPACE WITHOUT EVER BEING IN THE ESOPHAGUS. THE X-RAY CONFIRMATION OF PLACEMENT MISSED THIS DUE TO ITS POSITION BEING DIRECTLY BEHIND THE ESOPHAGUS. ADDITIONAL INFORMATION RECEIVED ON 04-JUN-2018 STATED THAT THE PATIENT IS CURRENTLY IN A LONG TERM ACUTE CARE FACILITY RECOVERING FROM THE ILLNESS. THE PATIENT RECOVERED WELL FROM THE SURGERY, AND WAS ABLE TO BE EXTUBATED BUT HIS MENTAL STATUS WAS ALTERED; UNKNOWN IF THIS WAS PRESENT BEFORE OR AFTER THE PATIENT'S ADMITTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470727 DH CPK NG TUBES UNKNOWN CORPAK NG TUBE KNT HALYARD HEALTH UNKNOWN-UN-CPK-NG TUBE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention