BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-CLEANING CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW, WET PAK

    MDR report key: 8324762 · Received February 10, 2019

    Report

    Report Number
    8030647-2019-00020
    Event Type
    Injury
    Date Received
    February 10, 2019
    Date of Event
    January 20, 2019
    Report Date
    November 18, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE DEVICE WAS RECEIVED. THE DEVICE WAS EVALUATED. THE FAILURE WAS NOT CONFIRMED. THE ROOT CAUSE IS UNKNOWN. ALL INFORMATION REASONABLY KNOWN AS OF 15-NOV-2019 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). 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 · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, M7269T306, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 08-FEB-2019 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 · 1

    IT WAS REPORTED THAT THE CURARIZED AND STRONGLY SEDATED PATIENT EXPERIENCED DESATURATION AND HYPOTENSION THAT ONLY RESOLVED WHEN THE CLOSED SUCTION CATHETER KIT WAS REMOVED. IN THE MORNING, AT 7AM, AN EMERGENCY REQUEST FOR A POLYPNEA PROBLEM WAS NOTED. THE PATIENT HAD AN OXYGEN SATURATION OF 45% WITH DESATURATION AND HYPOTENSION. THE PATIENT WAS HEAVILY SEDATED, THUS PATIENT CURARIZED. AFTER IMMEDIATELY CHANGING THE EXPIRATORY FILTER AND ENSURING THERE WAS GOOD PERMEABILITY OF THE VENTILATOR THE PATIENT WAS DE-COUNTED WHILE HE WAS NOT CONGESTED. DUE TO THE FACT THAT DESATURATION AND HYPOTENSION WERE RELATED TO POLYPNEA TRAPPING AND DYNAMIC HYPERINFLATION, THE VENTILATOR TRIGGERED ON ITS INSPIRATORY TRIGGER WHICH WAS CORRECTLY ADJUSTED, THE VENTILATOR WAS DISCONNECTED, WHICH IMPROVED THE PATIENT'S RESPIRATORY STATUS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117734 TURBO-CLEANING CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW, WET PAK VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 2276-5 M7269T306

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention