BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 10657991 · Received October 9, 2020

    Report

    Report Number
    3014527682-2020-00017
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 9, 2020
    Manufacturer
    ROI CPS, LLC
    Product Code
    OEZ
    UDI-DI
    20194717106002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ROI CPS, LLC IS INVESTIGATING THIS EVENT AND IS AWAITING MORE INFORMATION FROM THE COMPLAINANT. PICTURES WERE PROVIDED BY THE CUSTOMER AND THE TEARS APPEAR TO BE FROM THE METHODS OF STORING THE KITS AT THE END USER FACILITY. ROI CPS, LL HAS OPENED AN INVESTIGATION INTO THE ROOT CAUSE OF THIS EVENT, BUT THE INVESTIGATION IS STILL IN PROCESS.

    Description of Event or Problem · 1

    HOLES, THAT APPEARD TO BE TEARING, WERE DISCOVERED IN THE VENTED BAGS OF THREE VASCULAR PACKS. NO PATIENT CONTACT AND WAS DISCOVERED PRIOR TO SETTING UP THE CASE. THIS WAS FOUND ON ROI CPS, LLC VASCULAR PACK # 800204005 LOTS: 78113E, 78305E AND 75118E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124023 REGARD VASCULAR PACK-SPARTANBURG OEZ ROI CPS, LLC CV00357E 78113E, 78305E, 75118E 20194717106002

    Patients

    Seq Age Sex Outcome Treatment
    1