BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25325065 · Received May 28, 2026

    Report

    Report Number
    1423395-2026-00196
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OJH
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT CHLORAPREP PREACTIVATED IN THE PACK. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CHLORAPREP PREACTIVATED IN THE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501362 MEDLINE DBD-TOTAL HIP OJH MEDLINE INDUSTRIES, LP - SPT 26ABU751

    Patients

    Seq Age Sex Outcome Treatment
    1