BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3240463 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19280
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 1, 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). THE DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR LOT NUMBER H13A02017 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION, LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE INTEGRITY OF THE SEAL SURFACE WAS TESTED WITH NO LEAKS NOTED. THE INSIDE DIAMETER OF THE PATIENT CONNECTOR WAS MEASURED AND FOUND TO BE BELOW NOMINAL. IMPROVEMENTS WERE MADE TO THE MOLD AND THE MOLDING DEPARTMENT PROCEDURES TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 FOR THIS EVENT. IT WAS REPORTED THAT THE PATIENT CONNECTOR OF A UV FLASH TRANSFER SET THAT HAD A GAP BETWEEN THE TITANIUM ADAPTER AND THE TRANSFER SET WHEN IT HAD BEEN CHANGED OUT. THE TRANSFER SET WAS BEING USED WITH A PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340361 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13A02017

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER