BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD CS NEO/PED, 6 FR, Y-ADAPTER

    MDR report key: 13446412 · Received February 3, 2022

    Report

    Report Number
    8030647-2022-00026
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 24, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038938240
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03-FEB-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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT IS A DUPLICATE OF (B)(4)/ MW 8030647-2022-00001. NO FURTHER INFORMATION WILL BE SUBMITTED FOR (B)(4)/ MW8030647-2022-00026. REFER TO (B)(4)/ MW 8030647-2022-00001 FOR FUTURE CORRESPONDENCE. ALL INFORMATION REASONABLY KNOWN AS OF 23-FEB-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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT (B)(4). THE FOLLOWING INFORMATION: TRACHEAL ASPIRATE BEING OBTAINED BY PROPER PROCEDURE AND UPON ATTEMPT TO SUCTION AND CLEAR THE BALLARD CLOSED SUCTION CATHETER (WITH NORMAL SALINE), IT WAS NOTICED THAT SUCTION (VERIFIED TO BE ON AND FUNCTIONING) WAS NOT REACHING THE PATIENT'S AIRWAY THROUGH THE CATHETER. SUCTION TUBING, CATHETER AND MUCOUS COLLECTION SPECIMEN CONTAINER WERE TROUBLESHOOTED FOR LEAKS. ATTEMPTED TO SUCTION PATIENT'S AIRWAY AGAIN WITHOUT SUCCESS. AGAIN, NOTED BY FEEL AND HEARING, THE END OF THE SUCTION TUBING HAS SUCTION PRESENT, BUT THE SUCTION WAS NOT ACTUALLY REACHING THE CATHETER TIP WHILE DEPRESSING THE THUMB BUTTON. BALLARD WAS REMOVED AND A 6FR OPEN SUCTION WAS USED TO CLEAR BOTH THE SECRETIONS AND NORMAL SALINE THAT HAS BEEN INADVERTENTLY INSTILLED INTO THE PATIENT'S AIRWAY. PATIENT VITALS DECOMPENSATED-REQUIRED FIO2 FOR A SHORT PERIOD. A NEW BALLARD WAS USED TO OBTAIN AN ASPIRATE AND CONTINUED CLEARANCE OF THE AIRWAY. ADDITIONAL INFORMATION RECEIVED 18-JAN-2022 STATED THE "BALLARD MALFUNCTION RESULTED IN PATIENT DECOMPENSATION WITH NEED TO REMOVE BALLARD AND SUCTION AIRWAY MANUALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451205 BALLARD CS NEO/PED, 6 FR, Y-ADAPTER VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 196 30142957 00609038938240

    Patients

    Seq Age Sex Outcome Treatment
    1 28 DA Male Required Intervention