BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 11124546 · Received January 6, 2021

    Report

    Report Number
    8041187-2020-00907
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETERS HAD SAFETY MECHANISMS THAT WOULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: "PVK WHERE THE CORK HAS BEEN LOOSENED A LITTLE AS USUAL BEFORE PVK SETTING, BUT THEN THE MANDREL IS PULLED OUT AND WHITE CORK SHOULD BE PUT ON PVK IT LOOSENS A TRANSPARENT PART BEFORE THE WHITE CAP SO IT IS NOT POSSIBLE TO ATTACH THE WHITE THE CORK FOR PVK. VERY DIFFICULT TO TRY TO LOOSEN THE WHITE CAP WITH ONE HAND AND AT THE SAME TIME HOLD THE VESSEL ABOVE TO AVOID CARNAGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETERS HAD SAFETY MECHANISMS THAT WOULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "PVK WHERE THE CORK HAS BEEN LOOSENED A LITTLE AS USUAL BEFORE PVK SETTING, BUT THEN THE MANDREL IS PULLED OUT AND WHITE CORK SHOULD BE PUT ON PVK IT LOOSENS A TRANSPARENT PART BEFORE THE WHITE CAP SO IT IS NOT POSSIBLE TO ATTACH THE WHITE THE CORK FOR PVK. VERY DIFFICULT TO TRY TO LOOSEN THE WHITE CAP WITH ONE HAND AND AT THE SAME TIME HOLD THE VESSEL ABOVE TO AVOID CARNAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21181 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9264779

    Patients

    Seq Age Sex Outcome Treatment
    1