BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAY SAFE / JUER CATHETER EXT. 6IN

    MDR report key: 3214025 · Received July 3, 2013

    Report

    Report Number
    8030665-2013-00428
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K822543
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCE'S DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. MEDICAL RECORDS HAVE BEEN REQUESTED AND HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. AT THE CONCLUSION OF CLINICAL INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT THE CATHETER EXTENSION HAD A PIN SIZED HOLE AND DIALYSIS SOLUTION WAS LEAKING OUT OF THE EXTENSION. PT'S FATHER STATED THAT THERE WAS NO FLUID ON THE CYCLER. RN FROM PT'S CLINIC STATED THAT THE PT BIT A PIN SIZED HOLE INTO THE CATHETER EXTENSION, CAUSING A FLUID LEAK. AN RN ALSO STATED THAT THE PT ACQUIRED PERITONITIS, CATHETER WAS TAKEN OUT AND PT WAS ADMINISTERED ANTIBIOTICS. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304145 STAY SAFE / JUER CATHETER EXT. 6IN FKX REYNOSA MANUFACTURING 11CR08054

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other| R DIALYSIS TUBING| LIBERTY DIALYSIS CYCLER