BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 16152667 · Received January 12, 2023

    Report

    Report Number
    2243072-2023-00015
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 22, 2022
    Report Date
    January 16, 2023
    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

    H.6. INVESTIGATION SUMMARY: THE PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO FROM LOT #2253580 REGARDING ITEM #393234 WITH THE REPORTED COMPLAINT OF CANNULA MATERIAL IS LOOSE. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL #393234 AND LOT #2253580 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR CANNULA MATERIAL IS LOOSE AND NO SUCH TYPE OF DEFECT WAS FOUND IN THE RETENTION SAMPLES. SINCE NO SAMPLE AND ONE PHOTOGRAPH WAS SHARED, THE COMPLAINT WAS INVESTIGATED BASED ON THE PHOTOGRAPH AND DEVICE HISTORY REPORT REVIEW OF LOT NUMBER 2253580. FOR NEEDLE RETRACTION ISSUE, SINCE THE SAMPLES ARE NOT AVAILABLE FOR INVESTIGATION SO THE EXACT ROOT CAUSE COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL, INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE REPORTED LOT# 2253580 WAS NOT FOUND FOR THE REPORTED CATALOG# 393254. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER WHILE INTRODUCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAIN IS BEING RAISED FROM MINOR OT AS CUSTOMER FOUND THAT DURING CANNULATION WHEN ADVANCING THE CANNULA AND PULLING OUT THE STYLET THE STYLET IS VERY LOSE AND NOT GETTING ADEQUATE GRIPPING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER WHILE INTRODUCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAIN IS BEING RAISED FROM MINOR OT AS CUSTOMER FOUND THAT DURING CANNULATION WHEN ADVANCING THE CANNULA AND PULLING OUT THE STYLET THE STYLET IS VERY LOSE AND NOT GETTING ADEQUATE GRIPPING"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074396 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown