BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACH CARE CLOSED SUCTION SYSTEM FOR NEONATES, 5 F, Y-ADAPTER

    MDR report key: 2921141 · Received January 17, 2013

    Report

    Report Number
    8030647-2013-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING.THE SAMPLE WAS RETURNED TO KIMBERLY-CLARK FOR ANALYSIS AND FOUND TO BE MISSING THE TWO SIDE SKIVE HOLES.THE INVESTIGATION IS ONGOING.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 FROM (B)(6) STATING, "NURSE FOUND 195-4J'S TOP OF CATHETER ONLY HAVE 1 SIDE HOLE. NURSE FOUND IT DURING 1ST SUCTION."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
    26253 TRACH CARE CLOSED SUCTION SYSTEM FOR NEONATES, 5 F, Y-ADAPTER CLOSED SUCTION CATHETER BSY KIMBERLY-CLARK HEALTH CARE M1267T709

    Patients

    Seq Age Sex Outcome Treatment
    1