BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR SPRING 400ML

    MDR report key: 2063488 · Received April 19, 2011

    Report

    Report Number
    1423537-2011-00020
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 13, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS INITIATED INTO THE MATTER OF, "TUBING BROKE OFF" DURING USE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. WITHOUT DEVICE CAUSE FOR FAILURE COULD NOT BE DETERMINED OR THE ISSUE CONFIRMED. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE FILED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS DURING MANUFACTURING OF THE LOT. LOT 100601D5 WAS PRODUCED FOR CATALOG SU130-475, WHICH DOES NOT INCLUDE DRAIN TUBING. WITH THE INFORMATION PROVIDED AND SINCE A SAMPLE WAS NOT AVAILABLE, WE CANNOT CONCLUDE THAT THE WOUND DRAIN IS ONE OF CARDINAL HEALTH'S PRODUCTS.

    Description of Event or Problem · 1

    PATIENT UNDERWENT LUMBAR SURGERY AT REPORTING FACILITY ON (B)(6) 2011 WITH PLACEMENT OF SUSPECT MEDICAL DEVICE AT THE END OF THE SURGERY. ON (B)(6) 2011, WHILE A HEALTHCARE PROFESSIONAL WAS ATTEMPTING TO REMOVE THE DEVICE DRAIN, THE DRAIN TUBING BROKE OFF AT THE PATIENT'S SKIN LEVEL LEAVING A PORTION OF TUBING INSIDE THE PATIENT. ON (B)(6) 2011 THE PATIENT WAS TAKEN BACK TO SURGERY WHERE HE WAS PLACED UNDER GENERAL ANESTHESIA AND UNDERWENT EXPLORATION OF PREVIOUS SURGICAL WOUND SITE AND REMOVAL OF DRAIN TUBE FRAGMENT FROM SUSPECT MEDICAL DEVICE. PATIENT WAS DISCHARGED TO REHAB FACILITY ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR SPRING 400ML RESERVOIR GCY CARDINAL HEALTH SU130-475 100601D5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention