BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAY SAFE/ LUER LOCK CATHETER EXT 12 IN

    MDR report key: 4230801 · Received October 27, 2014

    Report

    Report Number
    8030665-2014-00835
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    FRESENIUS MED CARE NORTH AMERICA REYNOSA MFG
    Product Code
    KDJ
    PMA / PMN Number
    K904806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMITIES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED THAT THE PIN ON HER CATHETER FELL OUT WHEN SHE DISCONNECTED HERSELF AND DIALYSIS SOLUTION LEAKED DURING TREATMENT. UPON FOLLOW UP, PT STATED THAT AFTER SHE HAD DISCONNECTED THE NIGHT SHE CALLED INTO TECHNICAL SUPPORT, THE BLUE KNOB/CAP LOCATED ON THE VERY TIP OF THE CATHETER EXTENSION SET HAD FALLEN OFF. PT ALSO STATED THAT THERE WAS A LITTLE FLUID LEAKING. PT STATED SHE FEELS FINE AND HAS NOT FELT ANY ADVERSE EFFECTS. PT CONFIRMED HER EFFLUENT HAS REMAINED CLEAR AND WAS NOT PRESCRIBED ANY PROPHYLACTIC ANTIBIOTICS. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681207 STAY SAFE/ LUER LOCK CATHETER EXT 12 IN KDJ FRESENIUS MED CARE NORTH AMERICA REYNOSA MFG

    Patients

    Seq Age Sex Outcome Treatment
    1 PD SOLUTIONS| LIBERTY DIALYSIS CYCLER| LIBERTY CYCLER SET