BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIDION

    MDR report key: 5067962 · Received September 10, 2015

    Report

    Report Number
    8044004-2015-00005
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    January 30, 2015
    Report Date
    February 2, 2015
    Manufacturer
    COVIDIEN
    Product Code
    CCK
    PMA / PMN Number
    K980327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE NEONATAL FILTERLINE WAS NOT RETURNED FOR INVESTIGATION. INCIDENTS SUCH AS THIS CAN OCCUR IF THE FILTERLINE IS USED WITH A TRACHEOSTOMY TUBE THAT IS INCOMPATIBLE DIMENSIONALLY. THE FILTERLINE CAN GET STUCK ON AN INCOMPATIBLE TRACHEOSTOMY TUBE AND CAUSE THE USER TO HAVE DIFFICULTY WITH DISCONNECTION. THE DIRECTIONS FOR USE (DFU) FOR THE FILTERLINE ADVISES THE USER TO VERIFY, BEFORE USE, THAT THE FILTERLINE CAN BE EASILY CONNECTED AND DISCONNECTED FROM THE TRACHEOSTOMY TUBE CIRCUIT. THE DIFFICULT DISCONNECTION CAN CAUSE THE FILTER LINE TO SEPARATE. THE SPRING CAN THEN BECOME DISCONNECTED AND REMAIN AT THE OPENING OF THE TRACHEOSTOMY TUBE. FROM A PATIENT SAFETY PERSPECTIVE, ALL FILTERLINE COMPONENTS ARE DESIGNED TO BE LARGER THAN THE INNER DIAMETER OF THE TRACHEOSTOMY TUBE. THEREFORE THE PARTS REMAINING AT THE TRACHEOSTOMY TUBE OPENING WOULD NOT BE ABLE TO PASS THROUGH THE TUBE. THIS EXPLANATION WAS PROVIDED TO THE CUSTOMER AND NO ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A CUSTOMER DISCONNECTED A FILTERLINE FROM A TRACHEOSTOMY TUBE, THE FILTERLINE SEPARATED AND A SPRING REMAINED AT THE OPENING OF A PATIENT'S TRACHEOSTOMY TUBE. THE CUSTOMER WAS ABLE TO REMOVE THE SPRING WITH FORCEPS. THE PATIENT'S TRACHEOSTOMY DID NOT HAVE TO BE EXCHANGED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598865 ORIDION FILTERLINE H SET INFANT/NEONATAL CCK COVIDIEN 006324 Q1405022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention