BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 14576929 · Received June 2, 2022

    Report

    Report Number
    8041187-2022-00279
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHOTOS AND 124 REPRESENTATIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTOS, AN UNUSED END CAP AND A CONTAMINATED END CAP WAS OBSERVED. THE LEAKAGE DEFECT COULD NOT BE SEEN CLEARLY FROM THE PHOTOS RETURNED; HOWEVER, THE CUSTOMER HAS CONFIRMED THE SAMPLE IN PHOTO 1 IS CAVITY 27 AND THE SAMPLE IN PHOTO 2 IS CAVITY 29 WHICH IS THE ACTUAL LEAKAGE SAMPLE. SEVEN REPRESENTATIVE SAMPLES WERE RETURNED OF THE REPORTED BATCH, 1323888. ALL OTHER REPRESENTATIVE SAMPLES WERE RETURNED OF UNREPORTED BATCHES: TWO FROM 1113671, THREE FROM 1140590, ELEVEN FROM 1176226, SEVEN FROM 1294551, 38 FROM 1323867, AND 56 FROM 1359621. ALL THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. ONE OF THE SAMPLES FAILED THE VISUAL INSPECTION. A SINK MARK WAS OBSERVED ON THE END CAP LUER CONE TIP OF THE SAMPLE FROM BATCH 1323888 FROM CAVITY 29. A THROUGH HOLE WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED AND UNREPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PROBABLE ROOT CAUSE FOR THE REPORTED LEAKAGE COULD BE DUE TO THE SINK MARK HOLE AT THE LUER CONE TIP OF THE END CAP. THE AIR VENT MAY BE CHOKED DURING MOLDING AND CAUSE HOT AIR TO BE TRAPPED. THIS AFFECTS THE MATERIAL FLOW TO THE FINAL FILL AREA AT THE LUER CONE TIP. A PROJECT HAS BEEN INITIATED TO ADDRESS THIS ISSUE. 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 THE CAP WAS DAMAGED AND LEAKED WHILE USING THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTION OF THE VPS A SMALL HOLE WAS DETECTED IN THE MALE PART OF THE WHITE CAP WHICH LED TO BLOOD EXITING THE WHITE CAP EVEN THOUGH IT WAS ALREADY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159245 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1323888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown