BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 14430019 · Received May 18, 2022

    Report

    Report Number
    8041187-2022-00255
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 1-JUN-2022. H6. INVESTIGATION SUMMARY: THREE PHOTOS AND 111 REPRESENTATIVE SAMPLES (MIXED PRODUCTS AND BATCHES) WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE FIRST TWO PHOTOS, THE TEAM OBSERVED ONE SHELF CARTON OF BATCH 1294605 AND ONE 18G VENFLON PRO SAFETY USED SAMPLE OBSERVED WITH THE NEEDLE PIERCED THROUGH THE CATHETER. A BLUNT NEEDLE CANNOT BE SEEN CLEARLY FROM THE RETURNED PHOTOS. THE THIRD PHOTO SHOWS TWO SHELF CARTON LABELS OF BATCH 1294600 AND DOES NOT BELONG TO THE REPORTED COMPLAINT. OF THE 111 REPRESENTATIVE SAMPLES, 49 REPRESENTATIVE SAMPLES WERE RECEIVED FROM BATCH 1294605, 42 REPRESENTATIVE SAMPLES FROM BATCH 1294600 (DOES NOT BELONG TO REPORTED COMPLAINT), 12 REPRESENTATIVE SAMPLES FROM BATCH 8331822 (DOES NOT BELONG TO REPORTED COMPLAINT), AND 8 REPRESENTATIVE SAMPLES FROM BATCH 1170859. SAMPLES FROM BATCHES 8331822 AND 1170859 ARE NOT PRODUCED BY BD TUAS AND WILL NOT BE DISCUSSED IN THIS INVESTIGATION. THE 49 SAMPLES FROM BATCH 1294605 WERE SUBJECTED TO VISUAL INSPECTION AND 20 SAMPLES WERE RANDOMLY PICKED TO PERFORM PENETRATION TESTING. ALL SAMPLES PASSED THE ACCEPTANCE CRITERIA. 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. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS A 100% ONLINE AUTOMATED VISION INSPECTION SYSTEM THAT CAN DETECT AND REJECT PRODUCT NOT MEETING THE LIE DISTANCE (CATHETER TIP AND CANNULA BEVEL END POSITION) REQUIREMENT. IF THE NEEDLE PIERCED THROUGH THE CATHETER IN THE MANUFACTURING PROCESS, THE DEFECTIVE PART WOULD BE REJECTED BY THE AUTOMATED VISION INSPECTION SYSTEM AS THE PRODUCT WILL NOT HAVE ANY LIE DISTANCE. FROM THE RETURNED PHOTOS, A BLUNT NEEDLE CANNOT BE SEEN CLEARLY FROM THE PHOTOS. BLOOD WAS OBSERVED IN THE CATHETER. THIS INDICATES A SUCCESSFUL PENETRATION. IT WOULD NOT BE POSSIBLE TO USE THE PRODUCT IF THE PRODUCT HAS NEEDLE PIERCED THROUGH THE CATHETER. THEREFORE, THE PROBABLE ROOT CAUSE FOR THE NEEDLE THROUGH THE CATHETER COULD BE DUE TO THE USER HAVING PARTIALLY WITHDRAWING THE NEEDLE FROM THE CATHETER AND REINSERTING THE NEEDLE INTO THE CATHETER, THE NEEDLE PIERCED THROUGH THE CATHETER AND DAMAGED THE CATHETER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WENT THROUGH THE CATHETER WHILE USING THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, FROM POLISH TO ENGLISH: THE MATERIAL THE STYLET IS MADE OF IT DELAMINATES BEFORE REMOVING THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WENT THROUGH THE CATHETER WHILE USING THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, FROM POLISH TO ENGLISH: THE MATERIAL THE STYLET IS MADE OF IT DELAMINATES BEFORE REMOVING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802361 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1294605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown