BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUSCH AGT NASAL CUFFED ET 6.0MM

    MDR report key: 9290668 · Received November 7, 2019

    Report

    Report Number
    8040412-2019-00310
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    October 19, 2019
    Report Date
    October 21, 2019
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). OUTCOMES ATTRIBUTED TO ADVERSE EVENT- LIFE THREATENING CHECKED IN ERROR ON INITIAL MDR. THE ACTUAL SAMPLE WAS NOT RETURNED; HOWEVER, THE CUSTOMER SENT BACK SEVEN REPRESENTATIVE SAMPLES FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO OBVIOUS DEFECTS WERE OBSERVED. THE INSERTION DEPTH OF THE SAMPLES WERE MEASURED AND THEY WERE FOUND TO BE WITHIN SPECIFICATION. THE CONNECTOR ASSEMBLY FEATURES OF THE ENDOTRACHEAL TUBE WERE DESIGNED IN A WAY THAT THE CONNECTOR CAN BE REMOVED AND CONNECTED BACK TO THE TUBE WHEN THE TUBE IS REQUIRED TO BE CUT TO LENGTH. THE 15MM CONNECTOR SHOULD BE FIRMLY SEATED IN THE TRACHEAL TUBE TO PREVENT DISCONNECTION DURING USE AS STATED IN THE PRECAUTION SECTION OF THE IFU. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE ACTUAL SAMPLE WAS NOT RETURNED, AND THE RETURNED REPRESENTATIVE SAMPLES WERE FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE CONNECTOR SEPARATED FROM THE TUBE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS REPORTED THERE WAS INTERUPTION OF PATIENT TREATMENT WHEN THE DISCONNECTION HAPPENED BECAUSE THE USER HAD TO TAPE THE CONNECTION TO MAKE IT HOLD. PATIENT CONDITION WAS REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE CONNECTOR SEPARATED FROM THE TUBE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS REPORTED THERE WAS INTERRUPTION OF PATIENT TREATMENT WHEN THE DISCONNECTION HAPPENED BECAUSE THE USER HAD TO TAPE THE CONNECTION TO MAKE IT HOLD. PATIENT CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083710 RUSCH AGT NASAL CUFFED ET 6.0MM TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL SDN. BHD. 19GT63

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R NONE REPORTED.| NONE REPORTED.| NONE REPORTED.