BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN-UN-CPK-NG TUBE

    MDR report key: 6678701 · Received June 29, 2017

    Report

    Report Number
    3009124963-2017-00031
    Event Type
    Death
    Date Received
    June 29, 2017
    Date of Event
    June 3, 2017
    Report Date
    July 7, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    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 (B)(6) 2017 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 COMP-GHC-17-02096. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. .

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 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

    FDA MEDWATCH MW5070450 WAS RECEIVED WHICH STATED "CORPAK ENTERAL FEEDING TUBE NOT LABELED WITH 'NOT RECOMMENDED FOR INFANT/NEONATAL USE.' THIS IS NOT VISIBLE ANYWHERE ON THE PRODUCT PACKAGING. SIZE 8 FR TUBE PLACED IN INFANT WHICH RESULTED IN DUODENAL PERFORATION." ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2017 STATED THAT THE DEVICE WAS PLACED ON (B)(6)2017 AND THE ISSUE WAS NOTED ON (B)(6) 2017. SURGICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS BELIEVED THAT THE INSERTION OF THE 8 FR IN A NEONATE COULD BE A CONTRIBUTING FACTOR, BUT NOT THE SOLE FACTOR IN THE PATIENT'S DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 STATED THAT THE CORTRAK 2 DEVICE WAS NOT USED DURING PLACEMENT, AND THAT THE TUBE WAS PLACED NASALLY BY THE CLINICIAN. FURTHER INFORMATION COULD NOT BE PROVIDED WITHOUT PARENTAL RELEASE. LOT NUMBER COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458920 UNKNOWN-UN-CPK-NG TUBE DH CPK NG TUBES KNT HALYARD HEALTH 20-6438 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 129 DA Death| R