BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY IV CATHETER 20G

    MDR report key: 5495044 · Received March 11, 2016

    Report

    Report Number
    8041187-2016-00016
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 12, 2016
    Report Date
    March 11, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. SUSPECT MEDICAL DEVICE; DEVICE MANUFACTURE DATE: THE EXACT DEVICE USED IN THIS INCIDENT IS UNKNOWN. TWO POTENTIAL LOT NUMBERS HAVE BEEN PROVIDED FOR THE REPORTED CATALOG NUMBER. LOT 5265426, MEDICAL DEVICE EXPIRATION DATE: 9/30/2018, DEVICE MANUFACTURE DATE: 9/22/2015; LOT 5030237, MEDICAL DEVICE EXPIRATION DATE: 1/31/2018, DEVICE MANUFACTURE DATE: 1/30/2015. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT (B)(6), THE PATIENT HAD SURGERY FOLLOWING PHLEBITIS FROM THE SUSPECT DEVICE. ALTHOUGH IT IS UNKNOWN WHO PLACED AND OPERATED THE DEVICE, IT WAS REPORTED THAT THE RESCUE SERVICE AT THE FACILITY PLACES 50% OF THE VASCULAR ACCESS DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150857 BD VENFLON¿ PRO SAFETY IV CATHETER 20G INTRAVENEOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention