BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 15469483 · Received September 23, 2022

    Report

    Report Number
    8041187-2022-00552
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 27, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903932245
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1231152. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A PHOTOGRAPH WAS PROVIDED TO AID IN OUR INVESTIGATION. OUR ENGINEERS NOTED THAT THE RETURNED PHOTOGRAPH DISPLAYED AN EXPOSED NEEDLE, WITHOUT A PROPERLY ACTIVATED SAFETY MECHANISM. THE ISSUE HAS BEEN CONFIRMED. UNFORTUNATELY, A PHYSICAL SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER FAILED TO ACTIVATE AND COVER THE DIRTY NEEDLE TIP, RESULTING IN A NEEDLE STICK INJURY TO THE EMPLOYEE. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "LAST WEEK, UNFORTUNATELY, A NEEDLE STICK INJURY OCCURRED TO ONE OF OUR EMPLOYEES. THE SAFETY MECHANISM OF THE INDWELLING NEEDLE FAILED AND DID NOT AUTOMATICALLY SLIDE OVER THE TIP. THIS LEFT THE BLOODY NEEDLE TIP EXPOSED AND UNFORTUNATELY RESULTED IN A NEEDLESTICK INJURY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER FAILED TO ACTIVATE AND COVER THE DIRTY NEEDLE TIP, RESULTING IN A NEEDLE STICK INJURY TO THE EMPLOYEE. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "LAST WEEK, UNFORTUNATELY, A NEEDLE STICK INJURY OCCURRED TO ONE OF OUR EMPLOYEES. THE SAFETY MECHANISM OF THE INDWELLING NEEDLE FAILED AND DID NOT AUTOMATICALLY SLIDE OVER THE TIP. THIS LEFT THE BLOODY NEEDLE TIP EXPOSED AND UNFORTUNATELY RESULTED IN A NEEDLESTICK INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568178 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1231152 00382903932245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention