BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET

    MDR report key: 6089618 · Received November 9, 2016

    Report

    Report Number
    1820334-2016-01254
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Report Date
    May 15, 2017
    Manufacturer
    COOK INC
    Product Code
    BWC
    UDI-DI
    00827002062467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTION FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, 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 SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING A PROCEDURE THE BLADE OF THE CATHETER SET BROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AS OF THE DATE OF THIS REPORT NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739566 MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET BWC NEEDLE, EMERGENCY AIRWAY BWC COOK INC N/A 00827002062467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention