BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY STERILE CONTAINER

    MDR report key: 17341724 · Received July 18, 2023

    Report

    Report Number
    1416980-2023-03617
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 20, 2023
    Report Date
    September 8, 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

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

    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. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH WAS VISUALLY INSPECTED AND A SPLIT ON THE PORT OF THE BAG WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS DETERMINED TO BE A MANUFACTURING RELATED ISSUE WHICH OCCURRED DURING THE TUBING ASSEMBLY TO THE BAG. 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 LEAKED; FURTHER DESCRIBED AS "LEAKAGE FOUND AT THE CONNECTION SITE" AND "A TEAR WAS SEEN ON CLOSE OBSERVATION". 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201510 EMPTY STERILE CONTAINER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H23B27044 00085412007670
    840714 EMPTY STERILE CONTAINER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA H23B27044 00085412007670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TRANSFER SET