BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVENMORE HEMODIALYSIS CATHETER

    MDR report key: 1376133 · Received February 26, 2009

    Report

    Report Number
    1319211-2009-00006
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    January 16, 2009
    Report Date
    February 13, 2009
    Manufacturer
    MARTECH MEDICAL
    Product Code
    MSD
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE CATALOG NUMBER AND LOT NUMBER WERE NOT REPORTED. A SHIP HISTORY WAS CONDUCTED AND FOUND THE FOLLOWING LOTS OF EVENMORE HAD BEEN SHIPPED TO THE FACILITY IN THE LAST 6 MONTHS: CATALOG NUMBER 10303501 SHIPPED LOTS 958849, 951716, 958709 AND 958708. CATALOG NUMBER 10303502 SHIPPED LOTS 963080, 959336 AND 958742. CATALOG NUMBER 10303503 SHIPPED LOTS 963131, R56925, 960550 AND 958744/ NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE LOT PASSED ALL SPECIFICATIONS PRIOR TO RELEASE. REVIEW OF THE RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND WAS FOUND TO BE CRACKED. THE COMPLAINT SAMPLE WAS FORWARDED TO MARTECH FOR FURTHER EVALUATION. CONCLUSION: THE COMPLAINT INVESTIGATION IS CURRENTLY ONGOING. THE COMPLAINT SAMPLE HAS BEEN SENT TO MARTECH FOR FURTHER EVALUATION. ONCE MARTECH HAS COMPLETED THEIR INVESTIGATION, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    LUER CAME BACK CRACKED FROM DIALYSIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVENMORE HEMODIALYSIS CATHETER HEMODIALYSIS CATHETER MSD MARTECH MEDICAL NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1