BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 6159587 · Received December 9, 2016

    Report

    Report Number
    1820334-2016-01530
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    June 22, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL 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 (ALSO) PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU); SPECIFIC ITEMS ARE ADDRESSED SUCH AS ADVICE ON HOW TO PREVENT BREAKAGE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS BENT AND FRACTURED. ONE OF THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET BROKE OFF INSIDE A PATIENT (1820334-2016-01458). IN ADDITION, WITH ANOTHER ONE THAT ALMOST BROKE RECENTLY. (1820334-2016-01530). ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT PROVIDED AT THE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812208 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR