BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 7531285 · Received May 21, 2018

    Report

    Report Number
    8041187-2018-00142
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    April 22, 2018
    Report Date
    May 31, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION OF THIS COMPLAINT FROM BATCH # 7142150. THE NEEDLE CAP SAFETY MECHANISM ASSEMBLY HAS BEEN SEPARATED WITHOUT BEING ACTIVATED. THE SQUARE COVER OF THE SAFETY MECHANISM WAS REMOVED FOR VISUAL INSPECTION. IT WAS OBSERVED THAT THE SHARK FIN OF THE NEEDLE CAP WAS NOT IN BETWEEN THE CANNULA AND V-CLIP BEFORE V-CLIP ACTIVATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR BATCH # 7142150 AND NO ABNORMALITIES WERE OBSERVED. THE PROBABLE ROOT CAUSE COULD BE DUE INCORRECT SHARK FIN POSITION. DURING INSERTION OF THE V-CLIP INTO THE NEEDLE CAP, THE TOOLING WHICH DOES THE INSERTION OF THE V-CLIP IS LEANING MORE TO THE CANNULA SIDE. THIS HAS CAUSE THE V-CLIP TO PUSH THE SHARK FIN TO GO UNDERNEATH THE CANNULA. CAPA #(B)(4) WAS INITIATED TO ADDRESS THIS ISSUE, AND THIS BATCH WAS PRODUCED BEFORE THE IMPLEMENTATION.

    Additional Manufacturer Narrative · 1

    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 A NEEDLE STICK INJURY OCCURRED TO A PHYSICIAN WHILE USING A BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER. IN ADDITION, IT WAS REPORTED THE SAFETY MECHANISM FAILED TO ENGAGE AFTER USE. THE PHYSICIAN WENT "OH" COUNSELING AND RECEIVED BBP TESTING. THERE WAS NO REPORT OF ADDITIONAL MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371345 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7142150

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention