BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2863411 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06712
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE IDENTIFIED BECAUSE THERE WAS NO SAMPLE RETURNED TO BAXTER FOR EVALUATION. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) REGARDING A CONNECTION ISSUE WITH A MINICAP TRANSFER SET. THE NURSE STATED THAT A DISCONNECTION OCCURRED BETWEEN THE MINICAP TRANSFER SET AND THE TITANIUM ADAPTOR. THE PATIENT HAD THE TRANSFER SET SINCE (B)(6) 2012. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR TITANIUM ADAPTER