BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3072664 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10057
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE TITANIUM ADAPTER WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE NURSE CHANGED THE PRODUCT FOR THE PATIENT, THE TITANIUM ADAPTER COULD NOT CONNECT TO THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174267 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE