BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 X 200ML SYRINGE W/60" Y-TUBING AND

    MDR report key: 1051383 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00047
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    September 26, 2007
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: DEFECT COULD NOT BE DUPLICATED. CONCLUSIONS: DEVICE HISTORY RECORD FOR ASSEMBLE PROCESS WAS REVIEWED AND THERE ARE NO DISCREPANCIES REPORTED DURING THE MANUFACTURING OF THIS LOT. THE Y-TUBING HAS ONE SIDE SEPARATED FROM THE ENTIRE PART; THIS TUBING WAS BROKEN SINCE IT HAS THE REMAINING TUBING ADDED TO THE Y-TUBING. THE DEFECT WAS NOT DUPLICATED. WHEN IT WAS PULLED OFF THE OTHER SIDE, IT DETACHED ENTIRELY AND WAS NOT BROKEN. THIS PART NUMBER IS PROVIDED BY AN EXTERNAL VENDOR. THE CORRECTIVE ACTIONS PROPOSED BY THE VENDOR ARE LISTED BELOW. CORRECTIVE ACTIONS: SUPPLIER WAS NOTIFIED ABOUT COMPLAINT FOR TUBING WITH DAMAGE PROVIDED THE FOLLOWING CORRECTIVE ACTIONS: QUALITY ALERT IMPLEMENTED ON 13 SEPTEMBER, 2007.

    Description of Event or Problem · 1

    COVIDIEN SALES REPRESENTATIVE REPORTS THAT A CUSTOMER STATED, "THAT DURING THE INJECTION OF OPTIRAY CONTRAST INTO A PT, THE SALINE SIDE OF THE Y-TUBING SEPARATED. THE Y-TUBING WAS CONNECTED TO AN ANGIOCATH TUBING. THE INJECTION PROTOCOL WAS 5ML/SEC FOR A TOTAL VOLUME OF 75ML. THE TUBING SEPARATED AT 260 P.S.I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 X 200ML SYRINGE W/60" Y-TUBING AND DISPOSABLE SYRINGE, EMPTY FMF COVIDIEN 844021 7215102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK