BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS

    MDR report key: 15017855 · Received July 14, 2022

    Report

    Report Number
    3005951712-2016-00025
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    April 1, 2016
    Report Date
    July 14, 2022
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    PMA / PMN Number
    K991653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A POST INSPECTION RETROSPECTIVE REVIEW. 2016 INCIDENT.

    Description of Event or Problem · 0

    ON (B)(6) 2016, THE DISTRIBUTOR REPORTED TO RYMED THAT THEY HAD RECEIVED NOTIFICATION THAT THEIR CUSTOMER HAD EXPERIENCED AN ISSUE WITH THE PRODUCT. REPORTED THAT THE NURSE FOUND A BROKEN VALVE ON THE FLOOR IN THE PATIENT'S ROOM. THE PRODUCT HAD NOT BEEN ATTACHED TO A PATIENT. THE END CAP WAS STILL ATTACHED TO THE SET. NO PATIENT INJURY; NEVER REACHED THE PATIENT. 1 SAMPLE WAS RECEIVED (B)(6) 2016. IT WAS CONFIRMED THAT THERE WAS 1 INCIDENT WHERE THE CONNECTOR SEPARATED PRIOR TO USE. NO ADDITIONAL DETAILS SURROUNDING THE INCIDENT ARE AVAILABLE. REPORTED AS PRODUCT CODE 460207, LOT UNKNOWN. THIS REPORT IS A POST INSPECTION RETROSPECTIVE REVIEW. 2016 INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469489 INVISION-PLUS NEEDLELESS IV CONNECTOR FPA RYMED TECHNOLOGIES, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown