BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD TECHNOLOGY

    MDR report key: 7857527 · Received September 7, 2018

    Report

    Report Number
    8030647-2018-00530
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Report Date
    August 17, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, M18038L603, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 06-SEP-2018 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). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 8030647-2018-00528 FOR THE FIRST EVENT. REFER TO 8030647-2018-00529 FOR THE SECOND EVENT. REFER TO 8030647-2018-00531 FOR THE FOURTH EVENT. IT WAS REPORTED THE CONNECTION BETWEEN DUAL SWIVEL ELBOW (DSE) AND ENDOTRACHEAL TUBE CARBON DIOXIDE (ETCO2) SENSOR LOOSENED AND CAME OFF THE SUCTION CATHETER DURING SUCTIONING. THE SUCTION CATHETER AND FLEX CONNECTOR WERE REPLACED IMMEDIATELY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698789 CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD TECHNOLOGY VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 22103-4J M18038L603

    Patients

    Seq Age Sex Outcome Treatment
    1