BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L

    MDR report key: 10511758 · Received September 9, 2020

    Report

    Report Number
    8041187-2020-00545
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/17/2020. H.6. INVESTIGATION: TWO PHOTOS AND THREE REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTOS RECEIVED SHOWED THE TOP WEB OF THE PACKAGING AND THE FLOW CONTROL PLUG DETACHED FROM THE NEEDLE HUB TOGETHER WITH THE END CAP. THE NEEDLE PORTION CANNOT BE OBSERVED FROM THE RETURNED PHOTOS. THE THREE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, SEPARATION FORCE, END CAP DISASSEMBLE FORCE AND FLOW CONTROL PLUG DISSEMBLE FORCE FUNCTIONAL TEST. THESE SAMPLES PASSED ALL INSPECTIONS AND TESTING AND NO ABNORMALITIES WERE OBSERVED. NO ABNORMALITIES WERE OBSERVED AFTER ACTIVATION, AND THE NEEDLE IS ABLE TO BE CONTAINED WITHIN THE SAFETY MECHANISM. THE TEAM IS ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE PHOTOS RETURNED, HOWEVER NOT ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE SAMPLES RETURNED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L HAD THE SAFETY MECHANISM NOT FULLY COVER THE NEEDLE CAUSING A DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN APPLYING GREEN PVK IN PT¿S RIGHT ELBOW BEND, THE NEEDLE IS RETRACTED AND THE WHITE SCREW CAP / PLUG IS REMOVED. THE SMALL CONNECTOR PIECE THEN STAYS ON THE PLUG. WHEN TRYING TO PUT THE CONNECTOR PIECE ON THE CHAIR, I STICK THROUGH THE CHAIR AND DOWN INTO MY RIGHT THUMB WHICH IS USED TO FIX THE PVK WITH. PVK: THIS CONNECTOR COMES OFF WITH DISASSEMBLY OF WHITE PLUG ON PVK. STAB INJURY TO THE OUTER JOINT OF THE RIGHT THUMB. TO THE LEFT OF THE NAIL. THIS IS NOT THE FIRST TIME I HAVE EXPERIENCED THAT THE CONNECTOR PIECE COMES OFF WHEN THE PLUG IS TRIED TO BE REMOVED. THIS SHOULD BE FIXED BETTER SO THAT THE PLUG CAN STILL BE REMOVED WITH ONE HAND. THIS CONNECTOR PIECE GOES OFF WITH DISASSEMBLY OF WHITE PLUG ON PVK."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L HAD THE SAFETY MECHANISM NOT FULLY COVER THE NEEDLE CAUSING A DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN APPLYING GREEN PVK IN PT¿S RIGHT ELBOW BEND, THE NEEDLE IS RETRACTED AND THE WHITE SCREW CAP / PLUG IS REMOVED. THE SMALL CONNECTOR PIECE THEN STAYS ON THE PLUG. WHEN TRYING TO PUT THE CONNECTOR PIECE ON THE CHAIR, I STICK THROUGH THE CHAIR AND DOWN INTO MY RIGHT THUMB WHICH IS USED TO FIX THE PVK WITH. PVK: THIS CONNECTOR COMES OFF WITH DISASSEMBLY OF WHITE PLUG ON PVK. STAB INJURY TO THE OUTER JOINT OF THE RIGHT THUMB. TO THE LEFT OF THE NAIL. THIS IS NOT THE FIRST TIME I HAVE EXPERIENCED THAT THE CONNECTOR PIECE COMES OFF WHEN THE PLUG IS TRIED TO BE REMOVED. THIS SHOULD BE FIXED BETTER SO THAT THE PLUG CAN STILL BE REMOVED WITH ONE HAND. THIS CONNECTOR PIECE GOES OFF WITH DISASSEMBLY OF WHITE PLUG ON PVK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970724 VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9259493

    Patients

    Seq Age Sex Outcome Treatment
    1 Other