BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP PERF DRN

    MDR report key: 19665303 · Received July 3, 2024

    Report

    Report Number
    19665303
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 6, 2024
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A LIVER TRANSPLANT ON [DATE REDACTED]. DURING THE FOLLOW UP OFFICE VISIT OVER 3 WEEKS LATER, THE PHYSICIAN ATTEMPTED TO REMOVE THE JP (JACKSON-PRATT), BUT IT BROKE OFF. THE PATIENT WAS TAKEN TO THE OR (OPERATING ROOM) FOR REMOVAL OF THE REMAINING PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508098 JP PERF DRN CATHETER, IRRIGATION GBX CARDINAL HEALTH 200, LLC SU130-1311 12006156-OMNI

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female