BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3210315 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17702
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    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). AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED. VISUAL INSPECTION, LEAK TESTING AND CLEAR PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO SET WITH DIFFICULTY NOTED. SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM. 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). THE DEVICE HAS BEEN REQUESTED FOR RETURN TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED AND AN EVALUATION COMPLETED OR ADDITIONAL RELEVANT INFORMATION RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CHANGING THE TRANSFER SET IN USE FOR PERITONEAL DIALYSIS (PD) THE PATIENT CONNECTOR DID NOT CONNECT WELL WITH THE TITANIUM ADAPTER. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311833 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING TITANIUM ADAPTER