BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD TECHNOLOGY

    MDR report key: 8486793 · Received April 5, 2019

    Report

    Report Number
    8030647-2019-00041
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Report Date
    March 14, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-1427-2018
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, M7304L611, 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. A FIELD ACTION WAS INITIATED ON 07-FEB-2018 (PRODUCT ADVISORY NOTICE WAS SENT TO ALL POTENTIALLY IMPACTED CUSTOMERS). ALL INFORMATION REASONABLY KNOWN AS OF 04-APR-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

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2019-00039 FOR THE FIRST EVENT. REFER TO 8030647-2019-00040 FOR THE SECOND EVENT. IT WAS REPORTED, "THE FLEX TUBE THAT ATTACHES TO THE IN-LINE SUCTION REPEATEDLY DISCONNECTS WITH MINIMAL MANIPULATION. IT IS A VERY WEAK CONNECTION AND SLIDES OFF VERY EASILY." THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281102 BALLARD CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD TECHNOLOGY VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 2210-5 M7304L611

    Patients

    Seq Age Sex Outcome Treatment
    1