BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN-CPK-NG TUBE

    MDR report key: 8139224 · Received December 6, 2018

    Report

    Report Number
    9611594-2018-00223
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 13, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ALL INFORMATION REASONABLY KNOWN AS OF 06-DEC-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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBE WAS RUPTURED WITH A BALLOONING OF THE TUBE AT THE 45-46CM MARK. THIS OCCURRED WHILE THE DEVICE WAS IN USE, INSIDE THE PATIENT. THE ISSUE WAS NOTED ON CT SCAN, AND THE TUBE REMOVED FROM THE PATIENT. THERE WAS NO INJURY TO THE PATIENT. THERE HAD BEEN A TUBE BLOCKAGE THAT OCCURRED BETWEEN (B)(6) 2018. THE PATIENT'S WIFE REPORTED THAT A SMALLER SYRINGE (SMALLER THAN 60ML ENTERAL SYRINGE) WAS USED TO UNBLOCK THE TUBE, USING HOT WATER AND PRESSURE. PER A REVIEW BY THE NUTRITION NURSE, THE TUBE FAILURE WAS DUE TO USER ERROR. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018, THE REPORTER CONFIRMS THAT THE TUBE BALLOONED AND SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979087 UNKNOWN-CPK-NG TUBE DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. UNKNOWN DH CORTRAK DISPOSABLES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1