BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 5069210 · Received September 10, 2015

    Report

    Report Number
    8044004-2015-00003
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    September 19, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CCK
    PMA / PMN Number
    K980327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE: (B)(4). THE PRODUCT LOT NUMBER COULD NOT BE IDENTIFIED THEREFORE THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE NEONATAL FILTERLINE APPEARED TO HAVE BEEN USED WITH A TRACHEOSTOMY TUBE THAT WAS INCOMPATIBLE DIMENSIONALLY. THEREFORE THE FILTERLINE GOT STUCK ON THE TRACHEOSTOMY TUBE AND THE USER HAD DIFFICULTY IN DISCONNECTION. THE BIVONA TRACH THAT THE CUSTOMER USED HAS A SILICONE RING AROUND THE ADAPTER. 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 CAUSED THE FILTER LINE TO SEPARATE AND THE SPRING THEN REMAINED AT THE OPENING OF THE TUBE. THE CUSTOMER IS NOW USING A DIFFERENT TRACHEOSTOMY TUBE WHEN EMPLOYING MICROSTREAM CAPNOGRAPHY FILTER LINES. THE NEW PRODUCT IS NOW COMPATIBLE DIMENSIONALLY, RESOLVING THE REPORTED COMPLAINT. FROM A PATIENT SAFETY PERSPECTIVE, ALL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, A NURSE WAS ATTEMPTING TO SUCTION A PATIENT WITH A TRACHEOSTOMY TUBE. THE NURSE COULD NOT PASS THE SUCTION CATHETER AND A RESPIRATORY THERAPIST (RT) THEN INSPECTED THE TRACHEOSTOMY TUBE. THE RT FOUND THAT A SMALL PORTION OF A FILTER LINE CAME APART AND A SPRING WAS FOUND AT THE OPENING OF THE PATIENT'S TUBE. THE SPRING WAS REMOVED. 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
    599067 COVIDIEN FILTERLINE H SET INFANT/NEONATAL CCK COVIDIEN 006324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention