BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3212200 · Received July 9, 2013

    Report

    Report Number
    1416980-2013-17789
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    July 26, 2013
    Report Date
    July 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) 2013 WILL BE USED AS THIS IS THE DATE THE ISSUE WAS DISCOVERED WITH THE UNUSED COMPANION DEVICE DURING EVALUATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT HAS BEEN FOUND THAT THERE WAS NO CUSTOMER ALLEGATION AGAINST THE ACTUAL DEVICE. HOWEVER, UPON EVALUATION OF UNUSED COMPANION TRANSFER SETS FROM THE SAME LOT, THE INSIDE DIAMETER OF THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION. THIS IS REPORT 10 OF 12. DEVICE EVALUATION: AN UNUSED COMPANION 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 DEVICE 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WAS UNABLE TO CONNECT A MINICAP TRANSFER SET TO TITANIUM CONNECTOR OR A NON-BAXTER CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313810 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12I06038

    Patients

    Seq Age Sex Outcome Treatment
    1