BEUDAMED
    FDA Adverse Event Other Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 976776 · Received January 8, 2008

    Report

    Report Number
    9610849-2008-00001
    Event Type
    Other
    Date Received
    January 8, 2008
    Date of Event
    December 10, 2007
    Report Date
    December 11, 2007
    Manufacturer
    TIJUANA MANUFACTURING
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE UNIDENTIFIED: ROOT CAUSE CAN NOT BE DETERMINED SINCE SAMPLE IS NOT AVAILABLE. CONCLUSIONS: DEFECT WAS NOT CONFIRMED SINCE IT COULD NOT BE DUPLICATED. FUNCTIONAL AND VISUAL EVALUATIONS WERE NOT PERFORMED SINCE NO SAMPLE WAS RECEIVED FOR EVALUATION. DURING THE MANUFACTURING OF THIS LOT A PRESSURE TEST AT 1300 PSI, WHICH IS GREATER THAN THE PRESSURE USED 75-1200 PSI BY THE CUSTOMER. PRESSURE TEST METHOD WAS FOLLOWED ACCORDING INSTRUCTION NUMBER II064185 DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE ISSUE WERE FOUND. GOOD CLINICAL PRACTICE IS TO HAVE THE HEAD OF THE INJECTOR/SYRINGE POINTING DOWN TOWARDS THE FLOOR, AWAY FROM PT AND STAFF.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT IN THE LAST 2 WEEKS, THAT THEY HAD 3 SYRINGES, WHERE THE LUER LOCK CAME DETACHED DURING THE INJECTION OF THE LV GRAM PROCEDURE. NO INJURIES REPORTED. THE PROTOCOL USED FOR THE PROCEDURES WERE 700 PSI AT 36ML OF ISOVUE AT 12ML / SEC. A 48 INCH MEDI MEDICAL TUBING WAS USED BETWEEN THE SYRINGE AND PIGTAIL CATHETER. A LOT # SEARCH REVEALED NO OTHER SIMILAR COMPLAINTS. CUSTOMER DID NOT SAVE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 DISPOSABLE SYRINGE DXT TIJUANA MANUFACTURING 900101 7292103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other