BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 16992644 · Received May 24, 2023

    Report

    Report Number
    8041187-2023-00229
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    December 23, 2022
    Report Date
    May 30, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 NUMBERS 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. DHR REVIEWED WAS PERFORMED ON BATCH# 2201256.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER LEAKED FROM THE INJECTION PORT WHEN INSERTING IT FOR ANESTHETIC INDUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "20G CANNULA INSERTED FOR INDUCTION OF ANAESTHESIA WAS NOTED TO BE LEAKING THROUGH THE INJECTION PORT. WHEN IV FLUIDS WERE STOPPED, BLOOD BEGAN TO BACKFLOW THROUGH THE INJECTION PORT. CANNULA REMOVED, DISCARDED AND REPLACED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER LEAKED FROM THE INJECTION PORT WHEN INSERTING IT FOR ANESTHETIC INDUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "20G CANNULA INSERTED FOR INDUCTION OF ANAESTHESIA WAS NOTED TO BE LEAKING THROUGH THE INJECTION PORT. WHEN IV FLUIDS WERE STOPPED, BLOOD BEGAN TO BACKFLOW THROUGH THE INJECTION PORT. CANNULA REMOVED, DISCARDED AND REPLACED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370669 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2201256

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown