BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAP CLOSED SUCTION CATHETERS & ACCESSORIES

    MDR report key: 6012186 · Received October 7, 2016

    Report

    Report Number
    8030647-2016-00200
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 18, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER PROVIDED, M5360T511, WAS CONFIRMED AS AN INVALID LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS THE LOT NUMBER PROVIDED WAS INCORRECT. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. 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 · 1

    ADDITIONAL INFORMATION RECEIVED ON 29SEP2016 STATED THAT AN UNKNOWN FAILURE WITH NO HARM TO THE PATIENT REPORTED TO HAVE OCCURRED. THEREFORE THIS EVENT, 8030647-2016-00200, WILL NO LONGER BE CONSIDERED REPORTABLE. NO FURTHER INFORMATION ON THE COMPLAINT WILL BE FILED. 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.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2016-00199 FOR THE FIRST REPORT. IT WAS REPORTED BY THE SALES REP THAT AN INCIDENT OCCURRED REGARDING A BROKEN CATHETER DURING SUCTIONING. THE CATHETER BROKE FROM THE HUB AND BECAME LODGED IN THE PATIENT'S AIRWAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 29SEP2016 STATED THAT AN UNKNOWN FAILURE WITH NO HARM TO THE PATIENT REPORTED TO HAVE OCCURRED. THEREFORE THIS EVENT, 8030647-2016-00200, WILL NO LONGER BE CONSIDERED REPORTABLE. NO FURTHER INFORMATION ON THE COMPLAINT WILL BE FILED. PLEASE REFER TO 8030647-2016-00199 FOR THE REMAINING REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663672 VAP CLOSED SUCTION CATHETERS & ACCESSORIES HALYARD *CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 208 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1