BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 8162034 · Received December 13, 2018

    Report

    Report Number
    8041187-2018-00469
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 27, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903932245
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE EMPTY UNIT PACK AND 3 REPRESENTATIVE SAMPLES (BATCH #8200053) WERE RETURNED FOR INVESTIGATION. THE 3 REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND INNER THREAD MEASUREMENT. THE 3 REPRESENTATIVE SAMPLE PASSED THE ACCEPTANCE CRITERIA. NO ABNORMALITY OBSERVED ON THE RETURNED REPRESENTATIVE SAMPLES. DHR REVIEW SHOWS NO SIMILAR COMPLAINT WAS RECEIVED FOR BATCH #8200053. NO QN WAS RAISED FOR BATCH #8200053 (CATALOG: 393224) THERE IS NO SIMILAR QN ON RELATED DEFECT OR CONDITION FOR THE PAST 12 MONTHS. THE ROOT CAUSE CANNOT BE ESTABLISHED AS THERE IS NO ACTUAL SAMPLE OR PHOTO RETURNED. COMPLAINT TREND WOULD BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER HAD LOOSE CONNECTION DURING USE.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER HAD LOOSE CONNECTION DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998543 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER PERIPHERAL IV CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8200053 00382903932245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other