BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOH TUBE TRACHEOSTOMY AND TUBE CUFF

    MDR report key: 6090037 · Received November 9, 2016

    Report

    Report Number
    1820334-2016-01388
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 10, 2016
    Report Date
    April 12, 2017
    Manufacturer
    COOK INC
    Product Code
    JOH
    UDI-DI
    00827002555945
    PMA / PMN Number
    K093469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH VERSA TUBE. INVESTIGATION - EVALUATION: A REVIEW OF THE MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, DRAWING, QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON HAD RUPTURED CIRCUMFERENTIALLY; HOWEVER, THE SEPARATED SECTION OF THE BALLOON WAS NOT RETURNED FOR EXAMINATION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH VERSA TUBE. (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION WAS INITIALLY PROVIDED THAT THE BALLOON POPPED. UPON RECEIPT OF THE PRODUCT, IT WAS NOTED THAT THE BALLOON HAD BURST CIRCUMFERENTIALLY. THIS DID NOT REQUIRE INTERVENTION AND THE PATIENT HAD NO ADVERSE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742068 JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A 00827002555945

    Patients

    Seq Age Sex Outcome Treatment
    1