BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7128671 · Received December 19, 2017

    Report

    Report Number
    8030647-2017-00178
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Report Date
    February 7, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    TO BE DETERMINED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 21 FEB 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR (B)(4) WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN PATIENTS. THIS IS THE FORTH OF SEVEN REPORTS. REFER TO 8030647-2017-00175 FOR THE FIRST REPORT, REFER TO 8030647-2017-00176 FOR THE SECOND REPORT, REFER TO 8030647-2017-00177 FOR THE THIRD REPORT, REFER TO 8030647-2017-00179 FOR THE FIFTH REPORT, REFER TO 8030647-2017-00180 FOR THE SIXTH REPORT, REFER TO 8030647-2017-00181 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE PROVIDED IN THE PACKAGING HAS BEEN SLIPPING OFF DURING MECHANICAL VENTILATION. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2017, THE PATIENT IS FINE. THE DEVICE WAS IN USE FOR ONE WEEK. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909493 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 991093839 M7192T302

    Patients

    Seq Age Sex Outcome Treatment
    1