BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 8139755 · Received December 6, 2018

    Report

    Report Number
    8041187-2018-00453
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 27, 2018
    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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO, ONE USED SAMPLE AND THREE REPRESENTATIVE SAMPLES (BATCH #8019042, BATCH #8200407 AND BATCH #8051121) WERE RETURNED FOR INVESTIGATION. THE RETURNED PHOTO AND RETURNED USED SAMPLE SHOW THE NEEDLE SAFETY MECHANISM WAS NOT FULLY ACTIVATED AND THE NEEDLE IS EXPOSED AND NOT CONTAINED WITHIN THE NEEDLE CAP. AS THE ACTUAL SAMPLE IS A USED SAMPLE, IT 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 CONTAINED WITHIN THE SAFETY MECHANISM. THE NEEDLE CAP WAS REMOVED TO MEASURE THE NEEDLE HOLE DIMENSION. THE DIMENSION IS WITHIN THE ACCEPTANCE CRITERIA. THE 3 REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND SEPARATION FORCE TEST. THE 3 REPRESENTATIVE SAMPLES PASSED THE ACCEPTANCE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED AS THE ACTUAL SAMPLE AND REPRESENTATIVE SAMPLES PASSED THE ACCEPTANCE CRITERIA AND NO ABNORMALITY WAS OBSERVED. COMPLAINT TREND WOULD BE MONITORED. DHR REVIEW SHOWED ONE QUALITY NOTIFICATION WAS RAISED FOR THE BATCHES INDICATED. THE QN WAS FOR TIGHT SEPARATION THAT COULD PROBABLY BE RELATED TO THE CONDITION IN THE LAST 12 MONTHS. NO FORMAL CORRECTIVE ACTION IS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETERS HAD SAFETY FAILURE.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8051121. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2018-03-20. MEDICAL DEVICE LOT #: 8200407. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2018-08-16. 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 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS HAD SAFETY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980194 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR ADMINISTRATION SET FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other