BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE

    MDR report key: 9644694 · Received January 29, 2020

    Report

    Report Number
    3013986346-2020-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    December 31, 2019
    Report Date
    January 28, 2020
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Product Code
    DRC
    UDI-DI
    00858769006111
    PMA / PMN Number
    K172893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PROCEDURE WAS PERFORMED USING THE SAFESEPT NEEDLE FREE (SSNF). WHEN REMOVING THE WIRE FROM THE INTRODUCER, IT WAS NOTICED THAT THE DISTAL "J" PORTION OF THE WIRE WAS MISSING. THE DEVICE HISTORY WAS REVIEWED AND FOUND NO ANOMALIES. PROPER MATERIALS AND METHODS OF MANUFACTURING WERE UTILIZED. THE UNIT WAS NOT RETURNED FOR ANALYSIS. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER WAS UNABLE TO CROSS THE SEPTUM. THE WIRE WAS REMOVED FROM THE CANNULA, AND IT WAS NOTICED THAT THE DISTAL END WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106231 SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE NEEDLE FREE TRANSSEPTAL GUIDEWIRE DRC PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SSNF 000625 00858769006111

    Patients

    Seq Age Sex Outcome Treatment
    1