BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ IV CANNULA

    MDR report key: 14147558 · Received April 19, 2022

    Report

    Report Number
    2243072-2022-00505
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 27, 2022
    Report Date
    June 17, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. 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

    FOLLOW UP MDR FOR DEVICE EVALUATION. THE PHOTOS AND SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS AND SAMPLES ALONG WITH 10 RETENTION SAMPLES OF A VENFLON 22G IV CANNULA FROM LOT # 0112790 REGARDING MATERIAL NUMBER 391451 WITH THE REPORTED ISSUE OF BLOOD LEAKAGE FROM INJECTION PORT/VALVE - DURING CATHETER INSERTION. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR LEAKAGE AND NO LEAKAGE WAS FOUND IN THE TEN RETENTION SAMPLES. THE RETURN SAMPLES WERE TESTED FOR LEAKAGE. NONE OF THE THREE RETURN SAMPLES SHOWED ANY LEAKAGE IN THEM. THE INVESTIGATING TEAM REQUESTS FOR THE ORIGINAL SAMPLE TO BE SENT FOR INVESTIGATING THE REPORTED DEFECT AND TO ANALYZE THE ROOT CAUSE OF THE DEFECT. COMPLAINTS RECEIVED ON THIS DEVICE WILL BE CONTINUED TO BE MONITORED AND THE TRENDS WILL BE ANALYZED FOR FURTHER QUALITY IMPROVEMENT. IF SAMPLES ARE MADE AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR RE-INVESTIGATION ON THE SAMPLE RECEIVED. BASED ON THE CURRENT ANALYSIS THERE IS NO CAPA REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD VENFLON¿ IV CANNULAS LEAKED BLOOD FROM THEIR INJECTION PORTS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLOOD LEAKAGE FROM INJECTION PORT/VALVE - DURING CATHETER INSERTION. 3 INCIDENCES WITH SAME PRODUCT. REMOVED DEFECTED CATHETER FROM PATIENT VEIN AND DISCONTINUED THE PROCEDURE, INSERTED NEW CATHETER AT ANOTHER NEW SELECTED VEIN SITE OF PATIENT."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367437 BD VENFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 0112790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown