BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 24650740 · Received March 20, 2026

    Report

    Report Number
    1423395-2026-00046
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 20, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON 2/19/2026, THERE WAS SOME TYPE OF DEBRIS INSIDE THE ASEPTO. THE ITEM WAS NOTE USED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(4) ON 22-JAN-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 FACILITY ON 2/19/2026, THERE WAS SOME TYPE OF DEBRIS INSIDE THE ASEPTO. THE ITEM WAS NOTE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708102 MEDLINE MINOR GENERAL FDE MEDLINE INDUSTRIES, LP 25KLA704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown