BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN-CPK-NG TUBE

    MDR report key: 7679355 · Received July 11, 2018

    Report

    Report Number
    9611594-2018-00083
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    March 16, 2018
    Report Date
    June 18, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 10-JUL-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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT SUSTAINED A PERFORATED ESOPHAGUS AT THE GASTRIC JUNCTION THAT POSSIBLY OCCURRED WHILE USING THE CORTRAK UNIT. THE PATIENT INITIALLY HAD A SALEM SUMP TUBE IN PLACE. AN ATTEMPT WAS MADE TO ADVANCE THE SALEM SUMP BUT RESISTANCE WAS MET, THEREFORE THE HEALTHCARE PROVIDERS REMOVED THE SALEM SUMP AND ATTEMPTED TO INSERT THE NASOGASTRIC TUBE (NGT) WITH THE CORTRAK. IT IS UNKNOWN IF THE PERFORATION OCCURRED PRIOR TO THE NGT PLACEMENT WITH CORTRAK. A REVIEW OF THE CORTRAK TRACING NOTED IT WAS CLEAR THAT THERE WAS SOME RESISTANCE MET, BUT THE NURSE CONTINUED TO TRY AND ADVANCE THE NGT TUBE UNTIL THE CATHETER SPRUNG BACK AND POSSIBLY PERFORATED THE ESOPHAGUS AT THAT TIME. THE USER FACILITY REPORTED THIS INCIDENT DID NOT APPEAR TO BE RELATED TO A PRODUCT MALFUNCTION. ADDITIONAL INFORMATION RECEIVED 19-JUNE-2018 STATED WHEN THE NGT WAS PLACED, THE NURSE MET RESISTANCE BUT CONTINUED TO ADVANCE THE TUBE. IT APPEARED THAT THE CATHETER SPRUNG BACK ON ITSELF IN THE CORTAK TRACING AND KINKED. A KIDNEYS-URETHRA-BLADDER (KUB) X-RAY WAS PERFORMED AFTER PLACEMENT AND THE X-RAY WAS UNABLE TO LOCATE THE NGT. A COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS PERFORMED WHICH REVEALED A PERFORATION ON (B)(6) 2018. NO MEDICAL OR SURGICAL INTERVENTIONS WERE PERFORMED. THE PATIENT DIED ON (B)(6) 2018. THE USER FACILITY STATED THE DEATH WAS NOT RELATED TO THE REPORTED INCIDENT. THE PATIENT HAD AN UNDERLYING CARDIAC CONDITION WHICH WAS REPORTED TO BE THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519239 UNKNOWN-CPK-NG TUBE DH CPK NG TUBES KNT HALYARD HEALTH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SALEM SUMP TUBE