BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 18859478 · Received March 7, 2024

    Report

    Report Number
    3014527682-2024-00010
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Report Date
    March 7, 2024
    Manufacturer
    MEDLINE
    Product Code
    OEZ
    UDI-DI
    10193489074857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDLINE PTCA KIT WAS CONTAINED INSIDE A CONVENIENCE KIT MANUFACTURERD BY OUR FIRM (ROI CPS, LLC). ROI CPS, LLC SUBMITTED A CUSTOMER COMPLAINT TO MEDLINE ON (B)(6) 2024 AFTER RECEIVING A CUSTOMER COMPLAINT FOR THE MEDLINE ITEM CONTAINED IN A CONVENIENCE KIT. A SAMPLE FROM THE SAME LOT REPORTED BY THE END USER WAS SENT TO MEDLINE FOR EVALUATION, ROOT CAUSE IDENTIFICATION, AND APPLICABLE CORRECTIVE ACTIONS. ON 2/26/2024 MEDLINE PROVIDED A CLOSING RESPONSE LETTER DESCRIBING THEIR INVESTIGATION AND THE ROOT CAUSE OF THE ISSUE THEY IDENTIFIED. THE CLOSING RESPONSE LETTER FROM MEDLINE IS ATTACHED (B)(4) CLOSING RESPONSE). MEDLINE INDICATED THAT THE EVENT WAS LIKELY CAUSED BY OVER PRESSURIZATION OF THE CLOSED SYSTEM AND PROVIDED A REFERENCE TO THE DEVICE IFU WHICH DEFINES THE PRESSURE LEVELS THAT SHOULD NOT BE EXCEEDED WHILE USING THE DEVICE.

    Description of Event or Problem · 0

    STAFF NOTICED THERE IS A LEAK IN THE Y-CONNECTOR ON THE PTCA KIT. THE FLUSH BAG IS LEAKING IN TO THE WASTE BAG. THEY BELIEVE THE VALVE IS INCOMPETENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171560 MEDLINE PTCA KIT OEZ MEDLINE 650108610 0000101603 10193489074857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown