BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTROS

    MDR report key: 1162811 · Received September 9, 2008

    Report

    Report Number
    1319211-2008-00038
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 25, 2008
    Manufacturer
    ASH ACCESS
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE. THE EVAL OF THE RETURNED SAMPLE IS STILL ONGOING AT THE VENDOR, ASH ACCESS. A F/U REPORT WILL BE SUBMITTED ONCE THE EVAL BY ASH ACCESS HAS BEEN COMPLETED. HOWEVER, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS TYPE OF COMPLAINT. BASED ON INFO OBTAINED THROUGH THE CORRECTIVE ACTION, IT APPEARS AS IF THE CAUSE OF THE COMPLAINT IS A MFG ERROR. THIS PRODUCT IS MANUFACTURED AT VIA BIOMEDICAL. THE FOLLOWING INFO IS LISTED IN THE INSTRUCTIONS FOR USE TO HELP PREVENT CATHETERS FALLING OUT: CATHETER MUST BE SECURED/SUTURED FOR ENTIRE DURATION OF IMPLANTATION. CUT SUTURES FROM SUTURE WING. FOLLOW HOSPITAL PROTOCOL FOR REMOVAL OF SKIN SUTURES. FREE CUFF FROM SURROUNDING TISSUE. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    CUFF CAME OFF DURING PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTROS CHRONIC HEMODIALYSIS CATHETER SET MSD ASH ACCESS S08C07

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention