BEUDAMED
    FDA Adverse Event Death Summary report: N

    3002807350-2007-00001

    MDR report key: 820157 · Received February 2, 2007

    Report

    Report Number
    3002807350-2007-00001
    Event Type
    Death
    Date Received
    February 2, 2007
    Product Code
    FIR
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    JMS SINGAPORE PTE LTD IS THE OEM MFR FOR GAMBRO RENAL PRODUCTS TO PRODUCE PLUME SAFETY AVF NEEDLE SET. OUR EVALUATION OF DHR AND PRESERVED SAMPLES SHOWED THAT NO ABNORMALITY WAS ASSOCIATED WITH THESE COMPLAINED LOTS. WE ASSURE THAT OUR PRODUCTS' FORM, FIT AND FUNCTION MET THE REQUIRED SPECIFICATION AS NO DEFECTIVE WAS DETECTED VIA ALL THE TESTING AND EVALUATIONS. FURTHERMORE, ACCORDING TO INFO PROVIDED BY JMSNA, THIS INCIDENT WAS NOT RELATED TO OUR AVF NEEDLE, AND END-USER HAD COMMENTED THAT IT SHOULD BE AN OPERATIONAL ERROR DURING THE TREATMENT. HENCE, WE CONCLUDE THAT THIS COMPLAINT IS NOT RELATED TO OUR MFG PROCESS AND NO CORRECTIVE ACTION WILL BE APPLICABLE. LASTLY, JMSS WILL CONTINUE TO MAINTAIN THE GOOD QUALITY OF OUR PRODUCTS AND ENSURE THAT ONLY GOOD QUALITY PRODUCTS WILL BE DELIVERED TO CUSTOMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIR

    Patients

    Seq Age Sex Outcome Treatment
    1