BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    MDR report key: 1051382 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00044
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    September 14, 2007
    Report Date
    October 3, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: NO ROOT CAUSE CAN NOT BE DETERMINED SINCE DEFECT WAS NOT CONFIRMED. CONCLUSIONS: DEVICE HISTORY RECORD FOR FINAL PRODUCT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. PRESSURE TEST WAS APPLIED TO THE SAMPLE PROVIDED BY THE CUSTOMER, THIS TEST CONSISTS OF APPLYING A PRESSURE OF 1300 PSI FOR TEN SECONDS AND 1200 PSI FOR FIVE SECONDS. THE SAMPLE DOES NOT SHOW ANY DISCREPANCY DURING THIS EVALUATION. DURING THE MANUFACTURING OF THIS PART NUMBER, THE QUALITY DEPT PERFORMED A PRESSURE TEST WITH 1300 PSI ACCORDING TO THE INSTRUCTION NUMBER (B) (4) AND ALL THE SAMPLES PASS THIS TEST. THIS PRESSURE APPLIED AT 1300 PSI IS GREATER THAN THE PRESSURE USED (75-1200PSI) BY THE CUSTOMER. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS WILL BE APPLIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS: SYRINGE LUER LOCK TIP STRIPS WHEN ATTACHED TO HIGH PRESSURE LINE THUS CAUSING LINE TO BLOW OFF SYRINGE. NO PT INJURY - NO STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML (LINDEN LUER) DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900103 7152027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK