BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER, INJECTION VALVE

    MDR report key: 7434525 · Received April 16, 2018

    Report

    Report Number
    8041187-2018-00117
    Event Type
    Injury
    Date Received
    April 16, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 14, 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
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 50 REPRESENTATIVE SAMPLES WERE RETURNED FOR THE INVESTIGATION OF THIS COMPLAINT. VISUAL INSPECTION OF CATHETER AND CANNULA WERE PERFORMED AND NO ABNORMALITY WAS OBSERVED ON THE REPRESENTATIVE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7142284. INVESTIGATION SUMMARY: THE NON-CONFORMANCE OF THIS COMPLAINT COULD NOT BE DETERMINED AS ALL THE 50 REPRESENTATIVE SAMPLES PASS THE ACCEPTANCE CRITERIA. THE MANUFACTURING PROCESS INCLUDES AN AUTOMATED VISION INSPECTION MACHINE THAT WILL REJECT PARTS NOT MEETING LIE DISTANCE REQUIREMENT. A BROKEN CATHETER WILL AUTOMATICALLY BE REJECTED AS THE LIE DISTANCE WILL BE OUT OF SPECIFICATION. THEREFORE, THE REPORTED NONCONFORMANCE COULD HAVE OCCURRED OUT OF THE MANUFACTURING FACILITIES.

    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 DURING USE OF THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER WITH INJECTION VALVE THERE WAS AN ISSUE WITH A BROKEN CATHETER. THE CUSTOMER STATES ¿A NURSE WHILE REPLACING THE PLASTER AROUND THE INTRAVENOUS CANNULA, OBSERVED THE LACK OF THE INNER PART OF THE CANNULA, I.E. A PLASTIC TUBE. SHE IMMEDIATELY MADE A PALPATION EXAMINATION, DURING WHICH SHE SENSED A FOREIGN BODY UNDER THE SKIN, ABOUT 2 CM ABOVE THE SITE OF INJECTIONS. THE FOREIGN BODY WAS REMOVED.¿ THERE WAS NO REPORT OF FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277074 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER, INJECTION VALVE INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7142284

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention