BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP DRAIN 10F DRAIN JACKSON-PRATT 10F

    MDR report key: 22133449 · Received June 3, 2025

    Report

    Report Number
    MW5171039
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 19, 2025
    Report Date
    May 27, 2025
    Manufacturer
    CARDINAL / CARDINAL HEALTH 200, LLC
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A RETURN TO SURGERY FOR A "FRACTURED" JACKSON-PRATT DRAIN. PER MD, "DRAIN TUBING BROKEN WITH RETROGRADE FLOW OF BLOOD AND ANTEROGRADE FLOW OF BLOOD" JACKSON-PRATT DRAIN 10 FRENCH ROUND DRAIN, REF# SU130-0321, LOT #1250068. THIS RESULTED IN RETURN TO THE OPERATING ROOM FOR EVACUATION OF HEMATOMA AND REPLACEMENT OF THE DRAIN. NON-FUNCTIONING DRAIN HAS OCCURRED 3 TIMES. WE RECENTLY CHANGED TO CARDINAL PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78164 JP DRAIN 10F DRAIN JACKSON-PRATT 10F CATHETER, IRRIGATION GBX CARDINAL / CARDINAL HEALTH 200, LLC SU130-0321 1250068

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention