BEUDAMED
    FDA Adverse Event Other Summary report: N

    MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET

    MDR report key: 1491804 · Received October 1, 2009

    Report

    Report Number
    1820334-2009-00585
    Event Type
    Other
    Date Received
    October 1, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 3, 2009
    Manufacturer
    COOK, INC.
    Product Code
    BWC
    PMA / PMN Number
    K013916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE VISUAL DAMAGE TO THE TRAY, IT IS LIKELY THAT THIS DEVICE WAS SUBJECTED TO EXTREME SHIPPING AND HANDLING CONDITIONS, INCLUDING ATYPICAL CRUSHING FORCES. THE AFOREMENTIONED ISSUES CONTRIBUTED TO THE PROTECTORS COMING OFF, AND THE SCALPEL PROTRUDING THROUGH THE LIDSTOCK. PER SPECIFICATION, EACH TRAY IS VERIFIED TO ENSURE THAT THE NEEDLE PROTECTORS ARE ON THE PRODUCT, PRIOR TO FURTHER PROCESSING. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    WHEN THE PACKAGE WAS OPENED, THE SCALPEL PROTECTION WAS GONE FROM THE SCALPEL. AS A RESULT, A HOSPITAL RESIDENT WAS CUT. INJURED PERSON OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET BWC NEEDLE, EMERGENCY AIRWAY BWC COOK, INC. NA F2090354

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other