BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 12206775 · Received July 21, 2021

    Report

    Report Number
    8041187-2021-00620
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 23, 2021
    Report Date
    August 29, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING THIS PVK, NURSES STATE THAT WHEN YOU HAVE RECEIVED A BLOOD ANSWER, FIX THE PVK WITH THE BANDAGE AND THEN PULL OUT THE MANDIBLE A LITTLE BIT SO IT STARTS TO BLEED DIRECTLY FROM THE ENTRANCE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING THIS PVK, NURSES STATE THAT WHEN YOU HAVE RECEIVED A BLOOD ANSWER, FIX THE PVK WITH THE BANDAGE AND THEN PULL OUT THE MANDIBLE A LITTLE BIT SO IT STARTS TO BLEED DIRECTLY FROM THE ENTRANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098161 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1