BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACH CARE NEONATAL "Y" 8FR

    MDR report key: 1083555 · Received July 25, 2008

    Report

    Report Number
    8030647-2008-00012
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 24, 2008
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEWING THE COMPLAINT DATABASE, THIS IS THE FIRST COMPLAINT FOR THIS FAILURE MODE. THE INCIDENT SAMPLE WAS RECEIVED AND EVALUATION OF THE DEVICE NOTED THAT THE CATHETER SIDE PORTS WERE DIE CUT 2 TIMES RATHER THAN ONCE. THE REMAINING CATHETER MATERIAL WAS SIGNIFICANTLY REDUCED AND LIKELY SEVERED WHEN THE CATHETER WAS RETRACTED BY THE PHYSICIAN. IT SHOULD ALSO BE NOTED THAT IN THE DFU THERE IS A CAUTION THAT STATES "DO NOT USE FOR MORE THAN 24 HOURS." NEW PROCEDURES HAVE BEEN IMPLEMENTED FOR THE MANUAL PROCESS TO ASSURE THAT ONLY ONE HOLE WILL BE PUNCHED IN ONE CATHETER AT A TIME. IN ADDITION, 100% INSPECTION OF THE CATHETER TIP IS BEING CONDUCTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEM. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    A SUCTION CATHETER WAS SET UP ON THE PATIENT, THE USER FOUND THAT A CATHETER TIP WAS LOST FROM THE CATHETER. AN INVESTIGATION USING A BRONCHIAL FIBER SCOPE WAS PERFORMED IMMEDIATELY, WHICH CONFIRMED THE TIP STAYED INSIDE THE PATIENT'S AIRWAY. THE DOCTOR WAS ABLE TO RETRIEVE THE TIP FROM THE AIRWAY AFTER 6 HOURS. AS REPORTED BY THE USER FACILITY, THE INCIDENT DID NOT RESULT IN HEALTH DAMAGE TO THE PATIENT AND THE PATIENT'S CONDITION WAS REPORTED AS STABLE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH CARE NEONATAL "Y" 8FR TRACH CARE SUCTION BSY AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention