BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11947794 · Received June 7, 2021

    Report

    Report Number
    1416980-2021-03408
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 7, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H9: ADD CORRECTION/REMOVAL REPORT NUMBER FA-2020-055 (OMITTED ON INITIAL). H10: THE DEVICE WAS RECEIVED FOR EVALUATION; HOWEVER, AN EVALUATION WAS NOT PERFORMED AS THIS ISSUE IS RELATED TO A FIELD ACTION. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE TUBING OF A PERITONEAL DIALYSIS (PD) TRANSFER SET AND THE TWIST CLAMP WHICH RESULTED IN LEAK. THIS OCCURRED DURING USE OF THE DEVICE FOR PD THERAPY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT, HOWEVER, THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845855 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H20E22082 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1