BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL IV CATHETER

    MDR report key: 7349868 · Received March 19, 2018

    Report

    Report Number
    8041187-2018-00061
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 13, 2018
    Report Date
    April 19, 2018
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7233409. INVESTIGATION CONCLUSION: THE NON-CONFORMANCE OF THIS COMPLAINT COULD NOT BE DETERMINED AS THERE WAS NO SAMPLE OR PHOTO PROVIDED FOR THE INVESTIGATION OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VENFLON¿ PRO SAFETY PERIPHERAL IV CATHETER LEAKED BLOOD DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194420 BD VENFLON¿ PRO SAFETY PERIPHERAL IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7233409

    Patients

    Seq Age Sex Outcome Treatment
    1 Other