BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3923556 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21951
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H13I16036 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED. VISUAL INSPECTION USING A MICROSCOPE, LEAK TESTING, CLAMP FUNCTION TESTING AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE INTEGRITY OF THE SEAL SURFACE WAS TESTED WITH NO LEAKS NOTED. THE DIMENSIONAL INSPECTION OF THE RETURNED TRANSFER SET SAMPLE FOUND THE DIAMETER OF THE CATHETER CONNECTOR/PATIENT CONNECTOR TO BE WITHIN SPECIFICATIONS. THE SAMPLE WAS NOT CONFIRMED FOR THE REPORTED ISSUE AND A CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UV FLASH TRANSFER SET WOULD NOT CONNECT PROPERLY WITH A TITANIUM ADAPTER. IT BECAME LOOSE AFTER BEING CONNECTED TO THE TITANIUM ADAPTER. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399739 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13I16036

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER