BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3241193 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19315
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    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). AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED. LEAK TESTING AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO SET WITH DIFFICULTY NOTED. VISUAL INSPECTION WAS PERFORMED AND THE SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM BECAUSE THE SET CONTAINED A FLARED PATIENT ADAPTER. THE INSIDE DIAMETER OF THE CATHETER ADAPTER SHROUD APPEARED TO BE BELOW NOMINAL. CORRECTIVE ACTIONS WERE TAKEN IN (B)(4) 2013 AT THE MOLDING PROCESS TO INCLUDE REPLACEMENT OF MOLD CORES TO BRING ID INTO THE CENTER OF THE SPECIFICATION RANGE. IN ADDITION, SPECIFIC MEASUREMENT REQUIREMENTS WERE ADDED TO MOLDING DEPARTMENT PROCEDURES TO ENSURE CONSISTENCY OF MEASUREMENT. A FOLLOW UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED 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. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE EVALUATION CONFIRMED THE REPORTED CONDITION, BUT THE CAUSE OF THE FLARED PATIENT CONNECTOR COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. CORRECTION TO THE PREVIOUSLY REPORTED RESULTS OF SAMPLE EVALUATION. THE FOLLOWING WAS REPORTED IN ERROR AND DOES NOT APPLY TO THIS REPORT: "FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO SET WITH DIFFICULTY NOTED."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT CONNECTOR OF A UV FLASH TRANSFER SET COULD NOT BE FIRMLY CONNECTED WITH THE TITANIUM ADAPTER AT THE TIME OF PLACEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340573 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13A02017

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTOR