BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JPH 19FR RND FULL W/15FR TRO

    MDR report key: 15839722 · Received November 21, 2022

    Report

    Report Number
    1423537-2022-00862
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 29, 2022
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GBX
    UDI-DI
    00192253022219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING FILED FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT THAT WAS SUBMITTED ON 11/21/2021 DUE TO THE INVESTIGATION FINDINGS ARE AVAILABLE. DEVICE HISTORY RECORD (DHR) OF THE COMPLAINT LOT WAS REVIEWED. THE LOT WAS INSPECTED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. ROOT CAUSE FOR THE REPORTED CONCERN CANNOT BE IDENTIFIED WITH THE INFORMATION PROVIDED. IT IS RECOMMENDED TO STRICTLY FOLLOW THE INSTRUCTIONS PROVIDED IN THE INSTRUCTION FOR USE (IFU) DATA INCLUDED WITH THE PRODUCT TO ENSURE DRAINS ARE PROPERLY USED. AS PREVENTIVE ACTIONS, THE CUSTOMER WILL BE PROVIDED WITH A COPY OF THE INSTRUCTIONS FOR USE. NO FURTHER ACTION IS PLANNED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT DRAIN INSERTION WAS PERFORMED FOR POST BREAST SURGERY PATIENT WITH A DIAGNOSIS OF MALIGNANT TUMOR OF THE BREAST PART, UNSPECIFIED. PATIENT WAS DISCHARGED WITH 2 ROUND SILICONE DRAINS IN THE SURGERY SITE FOR DRAINAGE. ON SEPTEMBER 28 THAT THE DRAIN BROKE IN THE DISTAL PORTION NEAR THE END OF THE DRAIN AND THE PUMP. DRAIN PIECE WAS REPLACED. NO INJURY OR FURTHER SURGERY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2781365 JPH 19FR RND FULL W/15FR TRO CATHETER, IRRIGATION GBX CARDINAL HEALTH 200, LLC JP-HUR910 1201029 00192253022219

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female