BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT PERISAFE 18GA 3-1/2IN WEISS

    MDR report key: 10170376 · Received June 18, 2020

    Report

    Report Number
    2618282-2020-00049
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 18, 2020
    Product Code
    CAZ
    UDI-DI
    30382904002733
    PMA / PMN Number
    K953790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT KIT PERISAFE 18GA 3-1/2IN WEISS PRINTED MARK COMES OFF BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE CURRENTLY HAVING DIFFICULTIES WITH THE PDK SET FROM BD. WHEN USING NORMAL SKIN DISINFECTION PRODUCTS, THE PRINTED MARK ON THE CATHETER COMES OFF IMMEDIATELY AND IT IS NO LONGER POSSIBLE TO RECOGNIZE IF THE CATHETER WAS REMOVED COMPLETELY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT KIT PERISAFE 18GA 3-1/2IN WEISS PRINTED MARK COMES OFF BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE CURRENTLY HAVING DIFFICULTIES WITH THE PDK SET FROM BD. WHEN USING NORMAL SKIN DISINFECTION PRODUCTS, THE PRINTED MARK ON THE CATHETER COMES OFF IMMEDIATELY AND IT IS NO LONGER POSSIBLE TO RECOGNIZE IF THE CATHETER WAS REMOVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636004 KIT PERISAFE 18GA 3-1/2IN WEISS ANESTHESIA CONDUCTION KIT CAZ 400273 9274360 30382904002733

    Patients

    Seq Age Sex Outcome Treatment
    1 Other