BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3202796 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17041
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H13A02017 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. AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED. VISUAL INSPECTION, LEAK TESTING AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. DIMENSIONAL INSPECTION OF THE RETURNED TRANSFER SET SAMPLE IDENTIFIED THAT THE INSIDE DIAMETER OF THE CATHETER ADAPTER SHROUD WAS BELOW NOMINAL. IMPROVEMENTS WERE MADE TO THE MOLD AND MOLDING DEPARTMENT PROCEDURES. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD DIFFICULTY CONNECTING THE PATIENT CONNECTOR WITH THE TITANIUM ADAPTER WHEN CHANGING THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301949 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13A02017

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING TITANIUM ADAPTER