BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY STERILE CONTAINER

    MDR report key: 17336624 · Received July 17, 2023

    Report

    Report Number
    1416980-2023-03615
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 19, 2023
    Report Date
    August 17, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME: REMOVE: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE AND REPLACE WITH SYSTEM, PERITONEAL, AUTOMATIC DELIVERY D2B: CLASSIFICATION CODE: REMOVE: KDJ AND REPLACE WITH FKX. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A EMPTY STERILE CONTAINER LEAKED. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198181 EMPTY STERILE CONTAINER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H23B27044 00085412007670
    1642009 EMPTY STERILE CONTAINER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H23B27044 00085412007670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRANSFER SET