BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8030665-2005-00092

    MDR report key: 2254975 · Received December 20, 2005

    Report

    Report Number
    8030665-2005-00092
    Event Type
    Malfunction
    Date Received
    December 20, 2005
    Date of Event
    November 12, 2005
    Report Date
    December 19, 2005
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: NO INDICATION OF THE REPORTED DEFECT FOUND DURING DHR. LOT(S) MET ALL RELEASE CRITERIA. CONCLUSION: THE REPORTED DEFECT IS NOT CONFIRMED. NO SAMPLE HAS BEEN RECEIVED BY FMC. CORRECTIVE ACTION: FMC HAS IMPLEMENTED A STEP IN THE ASSEMBLY PROCESS OF SUBASSEMBLY (B)(4) TO ENSURE THAT THE CLEAR CAP BODY CONNECTOR ARE PROPERLY TIGHTENED PRIOR TO THE ASSEMBLY OF THE SHRINK WRAP STEP. REFER TO (B)(4). FMC WILL CONTINUE TO MONITOR FOR CHANGES IN EFFICACY AS NEEDED.

    Description of Event or Problem · 1

    RN WAS CONTACTED AND ADD'L INFO WAS RECEIVED REGARDING THIS EVENT ON (B)(6) 2005. REPORTEDLY, THE PT IS FINE AND NO FURTHER ILL EFFECT RELATED TO THIS EVENT. THE PT CONTINUES PERITONEAL DIALYSIS AS ORDERED. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FKX REYNOSA MANUFACTURING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI