BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10217908 · Received July 1, 2020

    Report

    Report Number
    8030647-2020-00039
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Report Date
    July 1, 2020
    Product Code
    BSY
    UDI-DI
    00609038938394
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 01 JUL 2020 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. 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 FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 8030647-2020-00038 FOR THE FIRST REPORT. REFER TO 8030647-2020-00040 FOR THE THIRD REPORT. REFER TO 8030647-2020-00041 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE "ET [ENDOTRACHEAL] TUBE [ETT] CLOGGED WITH TENACIOUS SECRETIONS." NO SPECIFIC INFORMATION WAS PROVIDED FOR THIS PATIENT. ADDITIONAL INFORMATION WAS RECEIVED 16-JUN-2020. THE USER FACILITY STATED "YOU CAN HEAR THE SECRETIONS 'RATTLING' EVEN THOUGH YOU HAVE JUST OR IN THE PROCESS OF SUCTIONING. IN SOME INSTANCES THEY DON'T GET ANYTHING OUT BUT CAN HEAR IT. SOMETIMES THEY WILL REMOVE THE PATIENT FROM THE VENT AND STRAIGHT CATH THEM TO GET THE SECRETIONS....IN SOME INSTANCES WHEN WE ARE NOT GETTING THE SECRETIONS THE XRAY IS NOT IMPROVING AND O2 [OXYGEN] REQUIREMENTS NOT IMPROVING THEY WILL BRONCH [BRONCHOSCOPY] THE PATIENTS AND WILL GET TONS OF SECRETIONS WITH PLUGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683327 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 227 UNKNOWN 00609038938394

    Patients

    Seq Age Sex Outcome Treatment
    1