BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 8206923 · Received December 31, 2018

    Report

    Report Number
    8041187-2018-00492
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 12, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    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: TWELVE REPRESENTATIVE SAMPLES FROM BATCH #8171255 WERE RETURNED FOR INVESTIGATION OF THIS COMPLAINT. DHR REVIEW SHOWS NO QUALITY NOTIFICATION WAS RAISED FOR THE BATCH IN THE LAST 12 MONTHS. NO ABNORMALITIES OBSERVED AFTER REVIEWING PREVENTIVE MAINTENANCE, CALIBRATION AND EQUIPMENT RECORDS. INVESTIGATION CONCLUSION: THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION, PENETRATION TEST AND INDICATION TIME TEST. THE REPRESENTATIVE SAMPLES PASSED THE ACCEPTANCE CRITERIA. NO ABNORMALITY WAS OBSERVED. ROOT CAUSE DESCRIPTION: AS THE SAMPLES PASSED THE ACCEPTANCE CRITERIA, THE ROOT CAUSE CANNOT BE DETERMINED. RATIONALE: COMPLAINT TREND WOULD BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER HAD FOREIGN MATTER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.(B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER HAD FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044757 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8171255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other