BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 6957209 · Received October 17, 2017

    Report

    Report Number
    8041187-2017-00130
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 3, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION: ONE (1) OPENED ACTUAL SAMPLE (CANNULA HUB ONLY) AND ONE (1) OPENED REPRESENTATIVE SAMPLE (CANNULA HUB ONLY) WERE RETURNED FOR THE INVESTIGATION OF THIS COMPLAINT. SAMPLE # 1 (BATCH NO 7151123, CATALOG NO. 393224) WAS SUBJECTED TO VISUAL INSPECTION. THE LUER LOCK PORTION OF THE CANNULA HUB WAS OBSERVED TO BE DEFORMED. FROM THE TOP VIEW, IT APPEARED THAT THE LUER LOCK HAS BEEN STRETCHED IN THE DIRECTION OF THE TORQUE NORMALLY APPLIED AT CONNECTION OF THE LUER LOCK. FROM THE SIDE VIEW, IT WAS OBSERVED THAT THE LUER LOCK WAS DEFORMED BY AN EXTERNAL UPWARD FORCE. THE MOLDING PROCESS AND MANUFACTURING PROCESS WERE REVIEWED. THE RELEASE OF MOLD PRESS NEAR THE LUER LOCK AREA WAS IN A HORIZONTAL DIRECTION AND IT IS NOT POSSIBLE TO CAUSE THE DAMAGE IN UPWARD DIRECTION. THE ASSEMBLY OF NEEDLE CAP TO CANNULA HUB STATION WAS REVIEWED. THE DIRECTION OF ASSEMBLY IS IN A DOWNWARD DIRECTION AND IT IS NOT POSSIBLE TO CAUSE THE DAMAGE. SAMPLE # 2 (BATCH NO. 6025188, CATALOG NO. 393264) WAS SUBJECTED TO VISUAL INSPECTION; NO ABNORMALITIES WERE OBSERVED ON THE LUER LOCK PORTION OF THE CANNULA HUB. THE NONCONFORMANCE OF THIS COMPLAINT COULD NOT BE DETERMINED AS THERE IS NO PROCESS IN THE MANUFACTURING THAT COULD HAVE CAUSE THE NONCONFORMANCE ON THE CANNULA HUB LUER LOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER LEAKS. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733467 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7151123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other