BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13335055 · Received January 24, 2022

    Report

    Report Number
    8030647-2022-00004
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    December 24, 2021
    Report Date
    March 18, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038938240
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 21-JAN-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 THE REPORTED LOT NUMBER, 30144156, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE DEVICE WAS EVALUATED AND THE FAILURE WAS NOT CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17-MAR-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.

    Additional Manufacturer Narrative · 0

    CORRECTION: LOT # 30144156 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 10-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

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00003 FOR THE FIRST EVENT. IMMEDIATELY AFTER INSTALLING THE DEVICE SALINE BEGAN GOING INTO MY PATIENT'S LUNGS INSTEAD OF THE SUCTION SYSTEM. THE PATIENT BEGAN TO DECOMPENSATE AND THE OXYGEN LEVEL DESATURATED. THE DEVICE WAS REPLACED AND THE PATIENT WAS QUICKLY SUCTIONED. ADDITIONAL INFORMATION RECEIVED 31-DEC-2021 VIA FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) STATED: DESCRIBE THE EVENT OR PROBLEM: RESPIRATORY THERAPIST (RT) WENT IN TO DO CARE ON MY MICRO PREEMIE PATIENT IN THE NEST BED. PATIENT WAS UNSTABLE ALL DAY, ON THE VENT WITH INO (NITRIC OXIDE), PATIENT SPO2 KEPT ON DROPPING, SO WE DECIDED TO GO IN TO REPOSITION AND SUCTION. AFTER ASSESSING PATIENT'S LUNG SOUNDS BILATERALLY, RT PROCEED TO ADVANCE THE SUCTION CATHETER WITH LOT NUMBER 30142957, REF 196, INTO THE ETT (ENDOTRACHEAL TUBE) TO SUCTION PATIENT. AFTER RETRACTING THE CATHETER, RT INSTILLED 1 ML OF SALINE INTO THE CATHETER TO CLEAR IT. NO VISIBLE SECRETIONS CAME THROUGH, SO RT INSTILLED 1 MORE ML INTO THE CATHETER. AFTER THIS, RT DETERMINED THAT SALINE WAS GOING INTO MY PATIENT'S LUNGS INSTEAD OF THE SUCTION SYSTEM. MY PATIENT BEGAN TO DECOMPENSATE, SO RT TOOK THE CATHETER OUT AND ATTACHED THE OLIVE TIP DIRECTLY TO THE ETT TO SUCTION THE AIRWAY. AFTER THE PATIENT RECOVERED, WE TROUBLESHOT THE SYSTEM AND FOUND THAT THE CATHETER WAS FAULTY AT THE VALVE. WE CHANGED IT WITH A NEW CATHETER WITH A DIFFERENT LOT NUMBER. SUCTION DEPRESSION BUTTON DOES NOT ALLOW FOR VACUUM PRESSURE TO REACH CATHETER. DOES NOT SUCTION AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999485 BALLARD CS NEO/PED, 6 FR, Y-ADAPTER BALLARD CS NEO/PED, 6 FR, Y-ADAPTER BSY AVANOS MEDICAL INC. 196 30144156 00609038938240

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA Female