BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWTON IQ W/STAY SAFE CYCLER SET

    MDR report key: 921340 · Received March 26, 2007

    Report

    Report Number
    8030665-2007-00016
    Event Type
    Malfunction
    Date Received
    March 26, 2007
    Date of Event
    February 25, 2007
    Report Date
    March 26, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    k811986
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT WAS REC'D FROM A PERITONEAL DIALYSIS PT WHO REPORTED AN EVENT. REPORTED WAS THAT SHORTLY AFTER STARTING HER DIALYSIS, SHE WOKE UP DUE TO FEELING WET. THE PT THEN VISUALLY NOTICED A LEAK AT THE SECOND STAY SAFE CONNECTOR. THE PROTECTIVE OVERWRAP WAS STILL IN PLACE OVER THE CONNECTOR. THE PT DISCONTINUED HER THERAPY ONCE SHE NOTICED THE LEAK AND THEN DISCONNECTED FROM THIS PD TUBING SET. THE PT NOTIFIED HER RN ON THE FOLLOWING DAY. THE PT WAS ADMINISTERED ONE PROPHYLACTIC DOSE OF VANCOMYCIN INTRAPERITONALLY FOR THIS INCIDENT. THE PT IS REPORTEDLY FINE WITH NO ILL EFFECT FROM THIS EVENT. THE PT CONTINUES TO DIALYZE INTRAPERITONEALLY. THE SAMPLE IS AVAILABLE FOR AN EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/STAY SAFE CYCLER SET PERITONEAL DIALYSIS TUBING SET FJK REYNOSA MANUFACTURING NA 6PR030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA