BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON IQ W/ STAY SAFE CYCLER SET

    MDR report key: 2251245 · Received September 12, 2011

    Report

    Report Number
    8030665-2011-00231
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 8, 2011
    Report Date
    September 12, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    050-87208
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OF NOTE: THE FACILITY WAS CONTACTED FOR ADDITIONAL INFO. ON (B)(6) 2011, ADDITIONAL INFO WAS RECEIVED AND CONFIRMED THAT THE PT RECEIVED MEDICAL INTERVENTION. DEVICE HISTORY RECORD REVIEW: ONE COMPLAINT HAS BEEN RECEIVED ON THIS LOT. SAMPLE ANALYSIS: NO SAMPLE WAS AVAILABLE FOR EVAL. CONCLUSION: THE REPORTED COMPLAINT IS UNCONFIRMED. EVENT DATA WILL TRENDED PER QUALITY DATA ANALYSIS PROCEDURE.

    Description of Event or Problem · 1

    A PT'S FATHER REPORTED DIFFICULTY WITH THE BLUE PIN GOING IN (PART THAT HOOKS TO PT) AND THAT WHEN HE UNHOOKED THE PIN FELL OFF. THE NURSE WAS CALLED FOR INFO REGARDING THIS INCIDENT. IT HAS BEEN LEARNED THAT THE PT RECEIVED ANTIBIOTICS FOR A POSITIVE CULTURE. THE NURSE REPORTED THAT THE PT HAS FULLY RECOVERED WITHOUT FURTHER INCIDENT. THE PT CONTINUES TO USE THIS PRODUCT WITHOUT FURTHER INCIDENT. THERE IS NO SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWTON IQ W/ STAY SAFE CYCLER SET PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA 11DR08016

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other| R NEWTON IQ DIALYSIS MACHINE