BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2991631 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05436
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    October 30, 2012
    Report Date
    February 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED DURING EVALUATION OF THE RETURNED SAMPLE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED A LOOSE CAP IN THE UNOPENED POUCH NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER HAD A MISASSEMBLED TRANSFER SET FOUND BEFORE USE. IT WAS REPORTED THAT A LOOSE CAP FROM THE PATIENT ADAPTER WAS FOUND INSIDE THE UNOPENED POUCH OF THE TRANSFER SET. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94856 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10L07041

    Patients

    Seq Age Sex Outcome Treatment
    1