BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 4121676 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33362
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE SAMPLE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE AND A MICROSCOPE, A DAMAGED PATIENT CONNECTOR WAS NOTED. A CLEAR PASSAGE TEST, CLAMP FUNCTION TEST, AND LEAK TEST WERE PERFORMED WITH NO ISSUES NOTED. AN INTEGRITY OF SEAL TEST WAS PERFORMED WITH NO ISSUES NOTED. THE INTERIOR DIAMETER OF THE PATIENT CONNECTOR WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE ISSUE OF A DAMAGED PATIENT CONNECTOR WAS IDENTIFIED DURING EVALUATION BUT THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONNECTOR OF A UV FLASH TRANSFER SET WOULD NOT CONNECT TO A TITANIUM ADAPTOR, (DETAILS NOT PROVIDED). THERE WAS NO REPORT OF 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
    602004 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H14C17028

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTOR