BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 12207065 · Received July 21, 2021

    Report

    Report Number
    8041187-2021-00623
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: "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. WHEN USING PVK FROM BD, WHICH WE USED BEFORE, YOU COULD DO THAT STEP WITHOUT SPILLING BLOOD.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL 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 LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "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. WHEN USING PVK FROM BD, WHICH WE USED BEFORE, YOU COULD DO THAT STEP WITHOUT SPILLING BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101019 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1