BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DOUBLE SWIVEL ELBOW

    MDR report key: 7201010 · Received January 17, 2018

    Report

    Report Number
    8030647-2018-00011
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 20, 2017
    Report Date
    February 28, 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
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H9: 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 20-MAR-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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    H9: 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 20-MAR-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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 08-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. 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 · 0

    ADDITIONAL INFORMATION RECEIVED ON 14-JAN-2018 STATED: HOW MANY FLEX TUBES CAME LOOSE? ALMOST ALL FLEX TUBES ATTACHED TO THE SUCTION CATH(ETER) BECAME DISCONNECTED. WERE THEY ON THE SAME PATIENT OR DIFFERENT PATIENTS? DIFFERENT PATIENTS. WHAT IS THE AGE, WEIGHT, GENDER OF THE PATIENTS? ALL ADULT PATIENTS¿.18-99 YEARS HOW LONG WAS THE FLEX ON THE PATIENT BEFORE IT CAME LOOSE, HOURS OR DAYS? APPROXIMATELY 1-2 DAYS. WAS THE FLEX LOOSE ON THE 15MM END (CLOSEST TO THE CATHETER)? THE SWIVEL ADAPTER CLOSEST TO THE CATH(ETER) ELBOW WHERE THE FLEX CATH(ETER) ATTACHES TO. WAS THERE ANY PATIENT INJURY AS A RESULT OF THE DISCONNECT? NO KNOWN PATIENT INJURY BUT THERE WAS A STAFF MEMBER THAT GOT SPLASHED IN THE FACE WITH MOISTURE FROM INSIDE THE CATH(ETER) WHEN THE FLEX TUBING POPPED OFF. IT WAS ALSO NOTED THAT F&P HEATED HUMIDIFICATION WAS USED, AND THAT IT SEEMED LIKE ONCE THE CATHETERS WARM UP AND HAVE SILICONE RESIDUE, THEY START POPPING OFF. ADDITIONAL INFORMATION RECEIVED ON 22-JAN-2018 STATED THAT THERE WAS NO ISSUE WITH THE CLINICIAN WHO GOT SPLASHED. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THERE IS NO INFORMATION PROVIDED REGARDING THE RETURN OF THE ACTUAL COMPLAINT PRODUCT TO THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 11-JAN-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. (B)(4).

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT EVENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2018-00012 FOR THE SECOND EVENT. IT WAS REPORTED THAT A FLEX TUBE THAT WAS ATTACHED TO THE SWIVEL ON THE MANIFOLD OF A CATHETER CAME LOOSE FROM THE CIRCUIT. AS A RESULT, IT DISCONNECTED THE PATIENT FROM THE VENTILATOR. USE OF THE PRODUCT WAS STOPPED AND THE CLINICIAN RETURNED TO A T-PIECE CONFIGURATION. THERE WAS NO REPORT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463869 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DOUBLE SWIVEL ELBOW VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 227 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown