BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE

    MDR report key: 7892994 · Received September 20, 2018

    Report

    Report Number
    8030647-2018-00597
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 29, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    Z-1427-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, M7242T302, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. 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 18-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 (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED NINE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING NINE DIFFERENT EVENTS. THIS IS THE NINTH OF NINE REPORTS. REFER TO 8030647-2018-00589 FOR THE FIRST EVENT. REFER TO 8030647-2018-00590 FOR THE SECOND EVENT. REFER TO 8030647-2018-00591 FOR THE THIRD EVENT. REFER TO 8030647-2018-00592 FOR THE FOURTH EVENT. REFER TO 8030647-2018-00593 FOR THE FIFTH EVENT. REFER TO 8030647-2018-00594 FOR THE SIXTH EVENT. REFER TO 8030647-2018-00595 FOR THE SEVENTH EVENT. REFER TO 8030647-2018-00596 FOR THE EIGHTH EVENT. IT WAS REPORTED THE "FLEX CONNECTOR KEPT POPPING OFF OF THE IN-LINE SUCTION." THERE WAS NO PATIENT INJURY REPORTED AND NO MEDICAL TREATMENT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735619 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 22703-5 M7242T302

    Patients

    Seq Age Sex Outcome Treatment
    1