BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6058122 · Received October 26, 2016

    Report

    Report Number
    8041187-2016-00074
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 20, 2016
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED THAT IT WAS WITHOUT THE SQUARE COVER. THE SAFETY MECHANISM (V-CLIP) WAS OBSERVED TO BE ACTIVATED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6111025. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACEMENT OF A 20 G X .32 MM BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER WITH INJECTION VALVE, A PIECE OF THE SAFETY MECHANISM DETACHED FROM THE DEVICE. THERE WAS NO REPORT OF INJURY, CLINICAL CONSEQUENCES, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709569 20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6111025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other