BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS,KIT,ACCESSORY,SAN DIEGO

    MDR report key: 19169427 · Received April 23, 2024

    Report

    Report Number
    3015173212-2024-00001
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 23, 2024
    Manufacturer
    MEDLINE - MEXICALI
    Product Code
    LRO
    UDI-DI
    40193489444002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "PACKAGING IS CRUMPLED ON A LARGE PORTION OF THE PACKAGES. SOME PERFORATED WITH BROKEN STOPCOCKS. WHEN UNPACKING FROM BOXES THE PACKAGES THEY WERE VISIBLE CRUNCHED. WHEN OPENING ITS CONTENTS THERE WERE VISIBLY BROKEN AND BENT COMPONENTS." A SAMPLE IS AVAILABLE FOR EVALUATION. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(6) ON (B)(6) 2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, "PACKAGING IS CRUMPLED ON A LARGE PORTION OF THE PACKAGES. SOME PERFORATED WITH BROKEN STOPCOCKS. WHEN UNPACKING FROM BOXES THE PACKAGES THEY WERE VISIBLE CRUNCHED. WHEN OPENING ITS CONTENTS THERE WERE VISIBLY BROKEN AND BENT COMPONENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948229 MTS,KIT,ACCESSORY,SAN DIEGO LRO MEDLINE - MEXICALI (10)23IMA251 40193489444002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown