BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 6046936 · Received October 21, 2016

    Report

    Report Number
    1416980-2016-16508
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2016. THE DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE AND IT WAS NOTED THAT THE FOAM WAS FULLY SEPARATED FROM THE MINICAP. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS UNDETERMINED. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED MINICAP A BAXTER TECHNICIAN DETERMINED THAT THE SPONGE WAS FULLY SEPARATED FROM THE MINICAP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700441 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD NA 15K27H15

    Patients

    Seq Age Sex Outcome Treatment
    1