BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH CARE CLOSED SUCTION SYSTEM FOR PEDIATRICS, Y-ADAPTER, 8 F

    MDR report key: 2905391 · Received January 9, 2013

    Report

    Report Number
    8030647-2012-00027
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 28, 2012
    Report Date
    December 11, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. THE DIRECTIONS FOR USE CAUTION, "KIMVENT SYSTEMS ARE INTENDED TO BE USED FOR 24 HOURS BEFORE CHANGING."INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. (B)(4): DEVICE NOT RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6), STATING, "INLINE SUCTION ADAPTOR TIP BROKE STRAIGHT ACROSS CAUSED LEAKING & WHISTLING. BABY REQUIRED RE-INTUBATION BECAUSE PIECE STUCK IN THE ENDOTRACHAL TUBE." KIMBERLY-CLARK 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 KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10428 TRACH CARE CLOSED SUCTION SYSTEM FOR PEDIATRICS, Y-ADAPTER, 8 F CLOSED SUCTION CATHETER BSY KIMBERLY-CLARK HEALTH CARE M2150T710

    Patients

    Seq Age Sex Outcome Treatment
    1