BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE TSUNAGU SET CAP KIT

    MDR report key: 3971335 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24855
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UV FLASH MINICAP PREP KIT CONTAINED PARTICULATE MATTER INSIDE THE DISCONNECT CAP. THE ISSUE WAS NOTICED WHEN THE USER OPENED THE PACKAGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446376 ENTERPRISE TSUNAGU SET CAP KIT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1