BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 8701915 · Received June 14, 2019

    Report

    Report Number
    1416980-2019-03293
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 20, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH NAKED EYE WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONAL TESTING, INCLUDING LEAK TESTING, CLEAR PASSAGE TESTING, CLAMP FUNCTION TESTING AND INTEGRITY TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. 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

    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 PERITONEAL DIALYSIS TRANSFER SET WAS LEAKING AT THE DISTAL END (AWAY FROM THE CATHETER) AT THE ¿JUNCTURE¿ OF THE TUBING AND THE WHITE TWIST CLAMP; THIS WAS FURTHER DESCRIBED AS ¿THE TAPE AROUND THE CONNECTIONS HAS A YELLOWISH DISCOLORATION¿. THIS WAS IDENTIFIED BY THE NURSE WHEN THE PATIENT CAME IN TO HAVE THEIR DRESSING CHANGED. THERE WAS NO DAMAGE OR DISCONNECTION NOTED. THE TRANSFER SET WAS REPLACED. THERE WAS NO 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
    494110 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME NA H18J04044 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1