BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 16529156 · Received March 13, 2023

    Report

    Report Number
    16529156
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    February 16, 2023
    Report Date
    February 16, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OES
    UDI-DI
    10195327245030
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PRODUCT-MEDLINE CATH LAB PACK. THE STERILE BLUE WRAP HAD A TEAR/HOLE WHEN THE PLASTIC WRAP WAS REMOVED. PRODUCT NOT USED DUE TO COMPROMISED INTEGRITY. MANUFACTURER RESPONSE FOR CARDIAC CATHETERIZATION KIT, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WILL OBTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677964 MEDLINE INDUSTRIES, INC. CARDIAC CATHETERIZATION KIT OES MEDLINE INDUSTRIES, INC. DYNJ82862A 22KBG750 10195327245030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown