BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L

    MDR report key: 11009485 · Received December 15, 2020

    Report

    Report Number
    8041187-2020-00832
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0080448, D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2023, H.4. DEVICE MANUFACTURE DATE: 3/20/2020. D.4. MEDICAL DEVICE LOT #: 0144811, D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2023, H.4. DEVICE MANUFACTURE DATE: 5/23/2020.

    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: 12/16/2020. H.6. INVESTIGATION: SIX PHOTOS AND TWO USED SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE FIRST AND SECOND PHOTO SHOWS TOP WEBS FROM BATCH 0144811 AND 0080448. THE THIRD PHOTO SHOWS A TRANSPARENT LIQUID LEAKING FROM THE INJECTION PORT. THE FOURTH AND FIFTH PHOTOS SHOW BLOOD LEAKING FROM THE INJECTION PORT. THE SIX PHOTO SHOWS TWO CANNULA HUBS WITH DIFFERENT VALVE POSITIONS, ONE OF THE VALVES HAD MOVED TOWARDS THE CANNULA HUB. UPON VISUAL INSPECTION OF THE USED SAMPLES, THE VALVE WAS OBSERVED TO HAVE MOVED TOWARDS THE CANNULA HUB LUER SIDE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE INJECTION VALVE MOVING WITHIN THE CANNULA HUB. CAPA# 1379444 HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE JUST BEEN INFORMED WE HAVE A MASSIVE PROBLEM WITH BD PRO-SAFETY (14 AND 16 G) IN OUR THEATRES. AS YOU CAN SEE FROM THE PHOTOGRAPHS BOTH BLOOD AND FLUIDS ARE LEAKING FROM THE PORT. THIS IS HAPPENING CROSS SITE (STH AND GUYS), WITH MULTIPLE LOT NUMBERS INVOLVED AND THEY ARE PRESENT IN 15 OMNICELL CABINETS. IT WILL BE DIFFICULT TO SEQUESTER THE OFFENDING ITEMS BUT I HAVE COPIED BOTH (B)(6) FOR THEIR ASSISTANCE ON HOW BEST TO MANAGE THIS SITUATION,. THE MRHA HAS BEEN NOTIFIED. I CANNOT STRESS THE URGENCY OF THIS SITUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE JUST BEEN INFORMED WE HAVE A MASSIVE PROBLEM WITH BD PRO-SAFETY (14 AND 16 G) IN OUR THEATRES. AS YOU CAN SEE FROM THE PHOTOGRAPHS BOTH BLOOD AND FLUIDS ARE LEAKING FROM THE PORT. THIS IS HAPPENING CROSS SITE (STH AND GUYS), WITH MULTIPLE LOT NUMBERS INVOLVED AND THEY ARE PRESENT IN 15 OMNICELL CABINETS. IT WILL BE DIFFICULT TO SEQUESTER THE OFFENDING ITEMS BUT I HAVE COPIED BOTH TARVINDER AND GREG FOR THEIR ASSISTANCE ON HOW BEST TO MANAGE THIS SITUATION,. THE MRHA HAS BEEN NOTIFIED. I CANNOT STRESS THE URGENCY OF THIS SITUATION.

    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 14GA 2.0MM OD 45MM L LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE JUST BEEN INFORMED WE HAVE A MASSIVE PROBLEM WITH BD PRO-SAFETY (14 AND 16 G) IN OUR THEATRES. AS YOU CAN SEE FROM THE PHOTOGRAPHS BOTH BLOOD AND FLUIDS ARE LEAKING FROM THE PORT. THIS IS HAPPENING CROSS SITE (STH AND GUYS), WITH MULTIPLE LOT NUMBERS INVOLVED AND THEY ARE PRESENT IN 15 OMNICELL CABINETS. IT WILL BE DIFFICULT TO SEQUESTER THE OFFENDING ITEMS BUT I HAVE COPIED BOTH TARVINDER AND GREG FOR THEIR ASSISTANCE ON HOW BEST TO MANAGE THIS SITUATION,. THE MRHA HAS BEEN NOTIFIED. I CANNOT STRESS THE URGENCY OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475442 VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1