BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORPAK NASOGASTRIC TUBE

    MDR report key: 7739259 · Received August 1, 2018

    Report

    Report Number
    9611594-2018-00104
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Report Date
    July 27, 2018
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 21-AUG-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).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE LOCATION OF THE HOLE ON THE NASOGASTIC (NG) TUBE WAS ON PORT OF THE TUBE WAS INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY AND NO FURTHER INFORMATION AVAILABLE ON THE EVENT.

    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 23-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 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 (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COTRAK NASOGASTRIC (NG) TUBE WAS INITIALLY PLACED ON A PATIENT IN THE INTENSIVE CARE UNIT (ICU). THE USER SAVED THE ELECTROMAGNETIC TRANSMITTING STYLET AND PLACED IT IN A BAG WHICH WAS TAPED TO THE PATIENT'S BED. AN UNSPECIFIED AMOUNT OF TIME LATER, THE COTRAK-PLACED NG TUBE WAS REMOVED AND A REGULAR CORFLO NG TUBE WITH A STYLET WAS INSERTED. THE CORFLO STYLET WAS DISCARDED AND THE ELECTROMAGNETIC TRANSMITTING STYLET STILL REMAINED TAPED TO THE BED. AN UNSPECIFIED AMOUNT OF TIME LATER, THE CORFLO NG TUBE HAD TO BE MANIPULATED AND THE ELECTROMAGNETIC TRANSMITTING STYLET WAS PLACED INSIDE NG TUBE. THIS ACTION PERFORATED THE THE TUBE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580911 UNKNOWN CORPAK NASOGASTRIC TUBE DH CPK NG TUBES KNT AVANOS MEDICAL, INC. UNKNOWN-UN-CPK-NG TUBE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1