BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 13048655 · Received December 20, 2021

    Report

    Report Number
    8041187-2021-01064
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 24, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE FIRST PHOTO, A TOP WEB WITH BATCH 1140760 WAS OBSERVED. THE SECOND PHOTO SHOWED A USED SAMPLE WITH EXPOSED NEEDLE AND SAFETY MECHANISM NOT ACTIVATED. THE THIRD PHOTO SHOWED A NEEDLE THROUGH CATHETER AND THE PRODUCT DOES NOT BELONG TO THE REPORTED COMPLAINT. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. AS NO SAMPLE WAS RETURNED, FURTHER INVESTIGATION CANNOT BE PERFORMED, AND THE ROOT CAUSE CANNOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETERS' SAFETY SHIELDS FAILED TO WORK PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY SHIELD IN VENFLON PRO SAFETY IS NOT WORKING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948028 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1140760

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown