BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 5163712 · Received October 21, 2015

    Report

    Report Number
    1416980-2015-39534
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Report Date
    November 16, 2015
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: 10/14/2013 - 10/17/2013. THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, A COMPANION SAMPLE WAS RECEIVED AND EVALUATED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. UNDERWATER PRESSURE TESTING WAS PERFORMED WITH NO LEAK DETECTED. THE SAMPLE MET ALL SPECIFICATIONS AND THE REPORTED CONDITION WAS NOT VERIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NOTICED IODINE LEAKING FROM THE CRACK IN THE MINICAP. THE MINICAP CRACKS AFTER THE PATIENT SECURES IT TO THE TRANSFER SET. THE PATIENT REPORTED THAT NO DAMAGE WAS OBSERVED PRIOR TO USING THE MINICAP AND THAT THE LEAK FROM THE MINICAP OCCURS ANYWHERE BETWEEN A FEW MINUTES TO AN HOUR AFTER SECURING THE MINICAP TO THE TRANSFER SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696581 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND GD895755

    Patients

    Seq Age Sex Outcome Treatment
    1