BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 20508781 · Received October 22, 2024

    Report

    Report Number
    1416980-2024-05985
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    June 24, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D4: LOT #: H23E17055 (PREVIOUSLY SUBMITTED AS H23C29022). CORRECTION MADE TO D4: EXPIRATION DATE: 05/17/2028 (PREVIOUSLY SUBMITTED AS 03/29/2028). CORRECTION MADE TO D4: UNIQUE IDENTIFIER (UDI) #: (B)(4) (PREVIOUSLY SUBMITTED AS (B)(4)) CORRECTION MADE TO H4: DEVICE MANUFACTURE DATE: 05/17/2023 (PREVIOUSLY SUBMITTED AS 03/29/2023). ADDITIONAL INFORMATION: H6 AND H11. H11: 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 DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE "VALVE" (TWIST SLEEVE) OF THE MINICAP TRANSFER SET WOULD NOT CLOSE COMPLETELY, WHICH RESULTED IN A LEAK. THIS OCCURRED AFTER USE OF THE DEVICE FOR PERITONEAL DIALYSIS 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
    2567287 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA H23E17055 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown