BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTH CATH LAB PACK

    MDR report key: 22720043 · Received August 5, 2025

    Report

    Report Number
    MW5174069
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Report Date
    July 28, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP-SPT
    Product Code
    OES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BUG FOUND IN PACK PACKAGED BY MEDLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569055 SOUTH CATH LAB PACK CARDIAC CATHETERIZATION KIT OES MEDLINE INDUSTRIES, LP-SPT 25DMG741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown