BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY STERILE CONTAINER

    MDR report key: 17335688 · Received July 17, 2023

    Report

    Report Number
    1416980-2023-03613
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 20, 2023
    Report Date
    August 16, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412007670
    PMA / PMN Number
    K833065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO A1: PATIENT IDENTIFIER: NONE (PREVIOUSLY SUBMITTED AS UNKNOWN). CORRECTION MADE TO A2-A6: NA (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO B6: NA (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO B7: NA (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO D10: NA (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO D2A: COMMON DEVICE NAME: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY (PREVIOUSLY SUBMITTED AS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE). CORRECTION MADE TO D2B: CLASSIFICATION CODE: FKX (PREVIOUSLY SUBMITTED AS KDJ). CORRECTION MADE TO F10/H6: HEALTH EFFECT - IMPACT CODES: REPLACE F26 WITH F27. H10: THE DEVICE WAS RECEIVED FOR EVALUATION WITH A WHITE SPIKE OR PATIENT CONNECTOR CONNECTED TO THE MOLDED PORT. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A SPLIT/CUT DOWN THE PORT OF THE DRAIN BAG. FUNCTIONAL TESTING INCLUDING CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING FAILED DUE TO THE LEAK FROM THE SPLIT IN THE BAG PORT. THE REPORTED CONDITION WAS VERIFIED. THE DIRECT CAUSE WAS MANUFACTURING RELATED ISSUE DURING THE PORT TUBE PROCESS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EMPTY STERILE CONTAINER HAD A CRACKED IN THE CONNECTION PORT. THIS WAS OBSERVED BEFORE USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615492 EMPTY STERILE CONTAINER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H23B27044 00085412007670
    491023 EMPTY STERILE CONTAINER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H23B27044 00085412007670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NI.