BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 1061098 · Received June 13, 2008

    Report

    Report Number
    1036844-2008-00082
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    September 13, 2007
    Report Date
    June 13, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: TWO NEEDLES WERE RETURNED FOR EVALUATION. THE SAMPLES WERE VISUALLY EXAMINED UNDER 10 - 25X MAGNIFICATION. IT WAS OBSERVED THAT SAMPLE #1 HAD A HORIZONTAL CRACK APPROXIMATELY 1 CM IN LENGTH DOWN THE HUB. SAMPLE #2 HAD TWO HORIZONTAL CRACKS, EACH APPROXIMATELY 1CM IN LENGTH, AS WELL AS SMALLER STRESS FRACTURES IN THE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELATED ISSUES WERE NOTED DURING MANUFACTURING OF THIS LOT. THE REPORTED COMPLAINT OF A NEEDLE HUB CRACK WAS CONFIRMED THROUGH VISUAL INSPECTION. THE POTENTIAL CAUSE OF THIS ISSUE APPEARS TO BE USE/PROCEDURAL RELATED SINCE THE NEEDLE HUB GETS ATTACHED TO THE LUER OF THE SYRINGE. MANAGEMENT WILL CONTINUE MONITORING SIMILAR REPORTS FOR ANY TREND THAT MAY OCCUR. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT INVOLVED A MALE PATIENT WITH DIABETES, THAT UNDERWENT SURGERY FOR LEG AMPUTATION. UPON INSERTION (NEEDLE VIA LEFT SUBCLAVIAN VEIN) THE PHYSICIAN REMOVED THE ARROW RAULERSON SYRINGE (ARS), WITH THE NEEDLE, AS HE PRE-CONNECTED. HE INSERTED THE NEEDLE INTO THE VEIN IN THE ATTEMPT TO ASPIRATE BLOOD; HOWEVER, THE SYRINGE FILLED WITH AIR. THE PHYSICIAN NOTED THAT THE HUB WAS BROKEN. IN A SECOND ATTEMPT, THE SET WAS OPENED AND THE PHYSICIAN VISUALLY INSPECTED THE NEEDLE, AND IT APPEARED TO BE "OKAY". THE PHYSICIAN REPEATED THE PROCESS. WHILE IN THE VEIN HE TRIED TO ASPIRATE BLOOD, AGAIN AIR WAS DRAWN INTO THE SYRINGE. HE NOTICED THE SECOND NEEDLE HUB WAS ALSO BROKEN. A THIRD ATTEMPT WAS MADE WITH A DIFFERENT LOT NUMBER AND THE ATTEMPT WAS SUCCESSFUL. THE CATHETER REMAINS IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTL., INC. ZF7032798

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention