BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DH CPK NG TUBES

    MDR report key: 15123208 · Received July 28, 2022

    Report

    Report Number
    9611594-2022-00103
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    April 29, 2022
    Report Date
    September 13, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. 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 26 JUL 2022 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). 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 AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 12 SEP 2022 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). 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 AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT VISITED THE CLINIC FOR A CLOGGED NASOGASTRIC (NG) TUBE, AFTER UNSUCCESSFUL ATTEMPT(S) TO UNCLOG THE TUBE, IT WAS REMOVED. AFTER REMOVAL, IT WAS DISCOVERED THAT THE DISTAL PORTION OF THE (NG) TUBE WAS NOT INTACT. AN UNSPECIFIED SERIOUS INJURY WAS REPORTED, NO MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 18JUL2022 REPORTED, THE RETAINED TUBE WAS CONFIRMED USING AN X-RAY, THE PATIENT REQUIRED AN ENDOSCOPIC PROCEDURE (ON (B)(6) 2022) TO REMOVE THE REMAINING NG TUBE PIECE, WHICH HAD BEEN IN PLACE FOR 11 DAYS, (PLACED ON (B)(6) 2022). THE PATIENT DID NOT EXPERIENCE ANY HEALTH ISSUE RELATING TO THE RETAINED NG TUBE.

    Description of Event or Problem · 0

    FDA MEDWATCH /FDA USER FACILITY REPORT # MW5110589, RECEIVED ON 07JUL2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287361 UNKNOWN DH CPK NG TUBES DH CPK NG TUBES KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown