BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 4123672 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33537
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE REPORTED PROBLEM OF A LOOSE PULL RING CAP. THE ASSIGNABLE CAUSE OF THE LOOSE PULL RING CAP WAS UNDERMINED. THE BATCH REVIEW WAS PERFORMED WITH NO ISSUES FOUND RELATED TO BATCH MANUFACTURING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND AN EVALUATION OF THE DEVICE IS CURRENTLY BEING PERFORMED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A CONNECTION ISSUE BETWEEN THE BLUE PULL RING CAP AND THE CATHETER CONNECTER OF THE TRANSFER SET. THE CUSTOMER OBSERVED THAT THE BLUE PULL RING CAP WAS LOOSELY CONNECTED TO THE CATHETER CONNECTOR OF THE TRANSFER SET. THIS WAS NOTICED BEFORE THE USE OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY AND NO MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599978 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H14A02032

    Patients

    Seq Age Sex Outcome Treatment
    1