BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED SUCTION SYSTEM FOR ADULTS, 12 F, DSE, WET PAK

    MDR report key: 7686278 · Received July 13, 2018

    Report

    Report Number
    8030647-2018-00444
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Report Date
    July 16, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HALYARD HEALTH RECEIVED ONE USED SUCTION CATHETER AND ONE USED FLEX CONNECTOR, INSIDE OPEN PRODUCT PACKAGING. THE MALE INSERT OF THE DSE (DOUBLE SWIVEL ELBOW) WAS EXAMINED. THE SAMPLE WAS EVALUATED AND THE REPORTED FAILURE WAS CONFIRMED. THE ROOT CAUSE WAS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. ALL INFORMATION REASONABLY KNOWN AS OF 08-AUG-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 PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 10-JUL-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).

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE SEPARATE PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2018-00445 FOR THE SECOND PATIENT. REFER TO 8030647-2018-00446 FOR THE THIRD PATIENT. REFER TO 8030647-2018-00447 FOR THE FOURTH PATIENT. REFER TO 8030647-2018-00448 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE FLEX CONNECTOR AND THE CLOSED SUCTION CATHETER. THE USER STATED THAT THE CONNECTION WAS LOOSE AND DISCONNECTED EASILY DURING USE. THE ISSUE WAS DISCOVERED DURING USE AND THE DEVICE WAS REPLACED WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528915 CLOSED SUCTION SYSTEM FOR ADULTS, 12 F, DSE, WET PAK VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 21606-4J M7333L608

    Patients

    Seq Age Sex Outcome Treatment
    1