BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CS ADULT, 14 FR, DSE

    MDR report key: 13430158 · Received February 2, 2022

    Report

    Report Number
    8030647-2022-00022
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Report Date
    May 31, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038939070
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02-FEB-2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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).

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02-FEB-2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 30145641 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 25 MAY 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

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2022-00023 FOR THE SECOND EVENT. REFER TO 8030647-2022-00024 FOR THE THIRD EVENT. REFER TO 8030647-2022-00025 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00029 FOR THE FIFTH EVENT. IT WAS REPORTED THE CLOSED SUCTION CATHETER WOULD NOT SUCTION. THE HEALTHCARE PROFESSIONAL WAS ¿UNABLE TO SUCTION THROUGH THE TRACH SITE." THE HEALTHCARE PROFESSION CHECKED THE SUCTION CANNISTER AND THE ORAL SUCTION AND BOTH WERE "WORKING FINE." THE HEALTHCARE PROFESSIONAL MANUALLY SUCTIONED THE PATIENT WITH A 14 FRENCH CATHETER AND IT WORKED WELL. AFTER TRYING EVERYTHING, THE HEALTHCARE PROFESSIONAL RECHECKED IN-LINE SUCTION CATHETER. ALL THIS TIME THE PATIENT WAS COUGHING FORCEFULLY AND THE OXYGEN SATURATION LEVEL WAS LOW. THE HEALTHCARE PROFESSION CHANGED THE IN-LINE SUCTION CATHETER AGAIN AND IT FINALLY WORKED.

    Description of Event or Problem · 0

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2022-00023 FOR THE SECOND EVENT. REFER TO 8030647-2022-00024 FOR THE THIRD EVENT. REFER TO 8030647-2022-00025 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00029 FOR THE FIFTH EVENT. IT WAS REPORTED THE CLOSED SUCTION CATHETER WOULD NOT SUCTION. THE HEALTHCARE PROFESSIONAL WAS ¿UNABLE TO SUCTION THROUGH THE TRACH SITE." THE HEALTHCARE PROFESSION CHECKED THE SUCTION CANNISTER AND THE ORAL SUCTION AND BOTH WERE "WORKING FINE." THE HEALTHCARE PROFESSIONAL MANUALLY SUCTIONED THE PATIENT WITH A 14 FRENCH CATHETER AND IT WORKED WELL. AFTER TRYING EVERYTHING, THE HEALTHCARE PROFESSIONAL RECHECKED IN-LINE SUCTION CATHETER. ALL THIS TIME THE PATIENT WAS COUGHING FORCEFULLY AND THE OXYGEN SATURATION LEVEL WAS LOW. THE HEALTHCARE PROFESSION CHANGED THE IN-LINE SUCTION CATHETER AGAIN AND IT FINALLY WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372589 BALLARD CS ADULT, 14 FR, DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 2210 30145641 00609038939070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown