BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS

    MDR report key: 14951663 · Received July 7, 2022

    Report

    Report Number
    3005951712-2016-00017
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    March 1, 2016
    Report Date
    July 7, 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.

    Additional Manufacturer Narrative · 0

    FOLLOW UP #01: CORRECTED THE 510K NUMBER (G.3) WHICH CONTAINED A TYPO IN THE INITIAL REPORT; CORRECTED FROM K991652 TO K991653.

    Description of Event or Problem · 0

    ON 03/28/2016, THE DISTRIBUTOR REPORTED TO RYMED THAT THEY HAD RECEIVED NOTIFICATION THAT THEIR CUSTOMER HAD EXPERIENCED AN ISSUE WITH THE PRODUCT. REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THE CAP FELL APRAT. NO PATIENT INJURY BECASUE IT NEVER REACHED THE PATIENT. 1 SAMPLE WAS RECEIVED 03/30/2016. IT WAS CONFIRMED THAT THERE WAS 1 INCIDENT WHERE THE CONNECTOR SEPARATED PRIOR TO USE. NO DETAILS SURROUDING THE INCIDENT IS AVAILABLE. REPORTED AS PRODUCT CODE 460207, LOT UNKNOWN. THIS REPORT IS A POST INSPECTION RETROSPECTIVE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504259 INVISION-PLUS NEEDLELESS IV CONNECTOR FPA RYMED TECHNOLOGIES, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown