BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY

    MDR report key: 16301294 · Received February 4, 2023

    Report

    Report Number
    8041187-2023-00046
    Event Type
    Malfunction
    Date Received
    February 4, 2023
    Date of Event
    January 12, 2023
    Report Date
    March 30, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. DHR REVIEWED WAS PERFORMED ON BATCH# 2173194 PRODUCTION HISTORY RECORD WERE REVIEWED. NO ABNORMALITY WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON¿ PRO SAFETY HEMOLYSIS OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: HIGH RATES OF HEMOLYSIS OCCUR WHEN BLOOD IS DRAWN FROM THE VENFLON. CORRECT PREANALYTICS, TRANSPORT CONDITIONS AND CENTRIFUGATION. AN INCREASED HEMOLYSIS RATE IS ONE OF THE RISKS ASSOCIATED WITH BLOOD COLLECTION VIA A PIVC.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON¿ PRO SAFETY HEMOLYSIS OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: HIGH RATES OF HEMOLYSIS OCCUR WHEN BLOOD IS DRAWN FROM THE VENFLON. CORRECT PREANALYTICS, TRANSPORT CONDITIONS AND CENTRIFUGATION. AN INCREASED HEMOLYSIS RATE IS ONE OF THE RISKS ASSOCIATED WITH BLOOD COLLECTION VIA A PIVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136193 BD VENFLON¿ PRO SAFETY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2173194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown