BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 11021249 · Received December 16, 2020

    Report

    Report Number
    1416980-2020-07857
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 20, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H9: CORRECTION/REMOVAL REPORT NUMBER IS FA-2020-055. H10: THE DEVICE WAS VISUALLY INSPECTED AND THE TUBING WAS BROKEN/TORN (SEPARATED FROM THE FEMALE CONNECTOR). PER VISUAL INSPECTION, IT WAS DETERMINED THAT THIS ISSUE IS RELATED TO A FIELD ACTION AND A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP TRANSFER SET FELL APART (THE TWIST AREA WHERE THE SET LOCKS AND OPENS) WHICH RESULTED IN LEAK. THIS WAS OBSERVED WHEN THE PATIENT WOKE UP IN THE MIDDLE OF THE NIGHT. THERE WAS NO PATIENT INJURY; HOWEVER THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AS A PRECAUTIONARY MEASURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489968 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1