BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 8139352 · Received December 6, 2018

    Report

    Report Number
    8041187-2018-00449
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 15, 2018
    Report Date
    January 9, 2019
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. 1 USED SAMPLE (BATCH #8173474) WAS RETURNED FOR INVESTIGATION. THE RETURNED USED SAMPLE SHOWS THE NEEDLE SAFETY MECHANISM WAS NOT FULLY ACTIVATED AND THE NEEDLE IS EXPOSED AND NOT CONTAIN WITHIN THE NEEDLE CAP. AS THE ACTUAL SAMPLE IS A USED SAMPLE, THE SAMPLE WAS SENT FOR DECONTAMINATION BEFORE INVESTIGATION. MANUAL ACTIVATION WAS PERFORMED ON THE USED SAMPLE, NO ABNORMALITY OBSERVED AFTER ACTIVATION. THE NEEDLE IS ABLE TO BE CONTAIN WITHIN THE SAFETY MECHANISM. THE NEEDLE CAP WAS REMOVED TO MEASURE THE NEEDLE HOLE DIMENSION. THE DIMENSION IS WITHIN THE ACCEPTANCE CRITERIA AND THERE IS NO POSSIBILITY OF NEEDLE BEING STUCK IN THE NEEDLE HOLE CHANNEL THAT COULD CAUSE INCOMPLETE ACTIVATION. THE NON-CONFORMANCE CANNOT BE DETERMINE AS THE USED SAMPLE PASSED THE ACCEPTANCE CRITERIA. COMPLAINT TREND WOULD BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY COVER OF BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER DID NOT DEPLOYED 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 THE SAFETY COVER OF BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER DID NOT DEPLOYED DURING USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980042 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER PERIPHERAL IV CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8173474 00382903932245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other