BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH CARE CLOSED SUCTION SYSTEM FOR PEDIATRICS, Y-ADAPTER, 6 F

    MDR report key: 3585733 · Received January 21, 2014

    Report

    Report Number
    8030647-2014-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Report Date
    December 24, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. ONE SAMPLE DEVICE WAS RETURNED TO KIMBERLY-CLARK FOR EVALUATION. THE RETURNED SAMPLE WAS IDENTIFIED AS DEVICE LOT M3105T702 AND WAS RECEIVED WITH A BROKEN Y-ADAPTER. THE TIP OF THE ADAPTER WAS BROKEN FROM THE Y-ADAPTER HOUSING. THE BREAK OCCURRED AT THE LOCATION WHERE THE MALE-TIP IS INSERTED INTO THE Y-ADAPTER HOUSING; HOWEVER, THE BOND JOINT THAT HELD THE TIP WITHIN THE HOUSING REMAINED INTACT. BOTH EDGES OF THE BROKEN SURFACE HAD VISIBLE STRESS CRACKING SUGGESTING THAT EXCESS TORQUE ON THE ADAPTER CONTRIBUTED TO THE BREAK. 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.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, ¿WHILE GOING TO SUCTION ETT, CATHETER COULD NOT ADVANCE. WHILE PULLING BACK TO RE-ATTEMPT, THE "Y" PORTION OF THE ETT SNAPPED OFF LEAVING TUBE WITHOUT VENTILATION. PATIENT'S OXYGEN SATURATION DECREASED TO THE 70'S, THEY WERE ABLE TO STABILIZE PATIENT WHILE RESPIRATORY THERAPY RECEIVED A NEW "Y" PIECE. THE PATIENT'S VITAL SIGNS REMAINED STABLE WHILE RESPIRATORY THERAPY WAS GETTING A NEW "Y" PIECE FOR THE ETT SETUP. THE RN HELD THE ETT TO THE BROKEN "Y" PIECE WITH FINGERS ON THE OUTSIDE OF TUBE WHICH CREATED A SEAL TO ALLOW THE PATIENT TO BE VENTILATED. A NEW "Y" PIECE WAS EASILY PUT ON AND THE BROKEN "Y" PIECE WAS REMOVED.¿ 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
    47505 TRACH CARE CLOSED SUCTION SYSTEM FOR PEDIATRICS, Y-ADAPTER, 6 F CLOSED SUCTION CATHETER BSY KIMBERLY-CLARK HEALTH CARE M3105T702

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO