BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3812035 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15515
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TRANSFER SET WAS RETURNED AND THE EVALUATION WAS COMPLETED. THE SAMPLE WAS VISUALLY INSPECTED WITH THE NAKED EYE, AS WELL AS WITH A MICROSCOPE. VISUAL INSPECTIONS A CRACK ON THE MAIN LIGHT BLUE BODY OF THE TRANSFER SET. LEAK, CLEAR PASSAGE, AND CLAMP FUNCTIONAL TESTING ALL PASSED. A BATCH REVIEW OF THE ASSOCIATED LOT NUMBER WAS PERFORMED AND NO ISSUES WERE NOTED DURING THE MANUFACTURE OF THE LOT. THE REPORTED CRACK ON THE MAIN BODY WAS VERIFIED DURING SAMPLE ANALYSIS, BUT THE CAUSE OF THE CRACK WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT BLUE MAIN BODY OF THE MINICAP TRANSFER SET WAS CRACKED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289931 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13H28033

    Patients

    Seq Age Sex Outcome Treatment
    1