BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULAIDE

    MDR report key: 4179974 · Received October 15, 2014

    Report

    Report Number
    3023468-2014-00004
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    March 24, 2009
    Report Date
    October 15, 2014
    Manufacturer
    BEEVERS MANUFACTURING AND SUPPLY, INC
    Product Code
    NHJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009 BEEVERS MANUFACTURING AND SUPPLY INC., (BMS) WAS NOTIFIED OF A COMPLAINT THAT ASSERTS THAT A CANNULAIDE DEVICE CAUSED A BREAKOUT OF STAPH INFECTION. SALTER LABS ACQUIRED BMS ON (B)(6) 2014 AND FOUND NO RECORD THAT BMS FOLLOWED-UP WITH THE COMPLAINT. MULTIPLE (SIX) ADDITIONAL ATTEMPTS OF CONTACT WERE MADE IN 2014 WITHOUT RESPONSE. THE BMS DISTRIBUTOR ADVISED SALTER LABS THAT ADDITIONAL TRAINING WAS PROVIDED TO THE END-USER MEDICAL FACILITY IN 2009 AND THERE HAVE BEEN NO REPORTS OF SIMILAR INCIDENTS SINCE THEN. THIS IS THE INITIAL AND FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654535 CANNULAIDE CANNULAIDE NHJ BEEVERS MANUFACTURING AND SUPPLY, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other