BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ IV CANNULA

    MDR report key: 15241517 · Received August 17, 2022

    Report

    Report Number
    2243072-2022-01354
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 22, 2022
    Report Date
    August 25, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4), INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN (B)(4) HAS BEEN LISTED IN MANUFACTURER NAME, CITY AND STATE AND MFR SITE AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2040075, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027, DEVICE MANUFACTURE DATE: 09-FEB-2022, MEDICAL DEVICE LOT #: 2020152, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027, DEVICE MANUFACTURE DATE: 20-JAN-2022, MEDICAL DEVICE LOT #: AN INVALID LOT # OF 2073117 WAS PROVIDED, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: NA. 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 25-JUL-2022 H6: INVESTIGATION SUMMARY THERE ARE FOUR SAMPLES AND NO PHOTOGRAPH ALONG WITH THE REPORTED COMPLAINT OF RUST. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL NUMBER 391591 AND LOT NUMBER 2040075 ,2020152 AND 2073117 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR RUST AND NO RUST WAS FOUND IN THE TEN RETENTION SAMPLES. THE INVESTIGATING TEAM HAS ANALYZED THE SAMPLES SENT AND IT WAS OBSERVED THAT THEY ARE REFERRING TO THE ¿EYE¿ A WINDOW LIKE HOLE THAT HAS BEEN CREATED FOR THE NURSES TO OBSERVE THE FLOW OF BLOOD IN THE CATHETER WHILE THEY PERFORM CANNULATION ON THE PATIENT. THE WINDOW WILL APPEAR AS RUST IF THE NURSE IS NOT AWARE ABOUT THE DIFFERENCE BETWEEN VENFLON AND VENFLON I. THE ROOT CAUSE IS CUSTOMER UNAWARENESS ABOUT THE UNIQUE FEATURE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 12 BD VENFLON¿ IV CANNULAS WERE RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUST HAS SEEN ON STYLET AFTER REMOVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 12 BD VENFLON¿ IV CANNULAS WERE RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUST WAS SEEN ON STYLET AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915270 BD VENFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown