BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.

    MDR report key: 4163619 · Received July 17, 2014

    Report

    Report Number
    8030665-2014-00554
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    FRESENIUS REYNOSA MANUFACTURING
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S MOTHER REPORTED THAT FOLLOWING HER DAUGHTER'S TREATMENT SHE STOOD UP AND WAS WALKING AROUND THE CYCLER. WHILE WALKING SHE FELT A TUG AND SAW THAT HER CATHETER EXTENSION HAD BROKEN. SHE CAUGHT THE BROKEN PART AND IMMEDIATELY CLAMPED THE LINE OFF. THERE WAS NO FLUID LEAK. THEY WENT TO THE CLINIC THE SAME DAY AND THE EXTENSION WAS REPLACED WITH A NEW ONE. DURING A FOLLOW UP THE PATIENT'S PD NURSE REPORTED THAT THE PATIENT HAS NOT HAD ANY INFECTIONS AND HER EFFLUENT HAS REMAINED CLEAR. SHE REPLACED THE BROKEN EXTENSION WITH A NEW ONE. THE PATIENT WAS TREATED WITH ONE DOSE OF PROPHYLACTIC ANTIBIOTIC VANCOMYCIN. THE BROKEN SET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419055 STAY SAFE/LUER LOCK CATHETER EXT. 12 IN. KDJ FRESENIUS REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR LIBERTY CYCLER| SINGLE CONN./EXT DL| LIVERTY CYCLER SET