BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 7938121 · Received October 5, 2018

    Report

    Report Number
    8041187-2018-00357
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    August 22, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 1 ACTUAL SAMPLE (BATCH# UNKNOWN) AND 4 REPRESENTATIVE SAMPLES (BATCH #8109028-(B)(4) PCS AND BATCH #8051125-(B)(4) PCS) WERE RETURNED FOR INVESTIGATION. DHR WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. SAMPLES RETURNED. ACTUAL SAMPLE: THE ACTUAL SAMPLE WAS SUBJECTED TO VISUAL INSPECTION OF THE CATHETER. A CLEAN CUT WAS OBSERVED ON THE CATHETER. ACTUAL SAMPLE (BROKEN CATHETER). THE MANUFACTURING PROCESS WAS REVIEWED AND THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD CAUSE THIS NONCONFORMANCE. THERE IS A 100% AUTOMATED VISION INSPECTION THAT WOULD REJECT THE PARTS THAT FAIL THE LIE DISTANCE. A BROKEN CATHETER WOULD AUTOMATICALLY BE REJECTED AS THE LIE DISTANCE WOULD BE OUT OF SPECIFICATION. THEREFORE THE NONCONFORMANCE COULD HAVE OCCURRED OUT OF THE MANUFACTURING FACILITIES. BASED ON THE CLEAN CUT OBSERVED ON THE BROKEN CATHETER OF THE ACTUAL RETURNED SAMPLE, THE SAMPLE COULD PROBABLY BE CUT BY SHARP OBJECT. FROM THE BROKEN EDGE OF THE CATHETER, NO STRETCHED PHENOMENON OR ELONGATION OF THE CATHETER TUBING COULD BE OBSERVED TO INDICATE ANY ISSUE WITH THE TUBING MATERIAL WHICH COULD HAVE CAUSED THE BREAKAGE. REPRESENTATIVE SAMPLES: THE 4 REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. ALL THE REPRESENTATIVE SAMPLES PASSED THE ACCEPTANCE CRITERIA. INVESTIGATION CONCLUSION: THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD CAUSE THIS NONCONFORMANCE. THERE IS A 100% AUTOMATED VISION INSPECTION THAT WOULD REJECT THE PARTS THAT FAIL THE LIE DISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PLACEMENT OF A BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER THE NEEDLE BROKE AND REMAINED IN THE VEIN. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM VIA AMBULANCE. AN ECHO WAS DONE TO DETERMINE PLACEMENT OF THE NEEDLE, AND THE PATIENT WAS TAKEN TO THE SURGERY DEPARTMENT FOR FURTHER SURGICAL REMOVAL OF THE NEEDLE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT OF A BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER THE NEEDLE BROKE AND REMAINED IN THE VEIN. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM VIA AMBULANCE. AN ECHO WAS DONE TO DETERMINE PLACEMENT OF THE NEEDLE, AND THE PATIENT WAS TAKEN TO THE SURGERY DEPARTMENT FOR FURTHER SURGICAL REMOVAL OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778638 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention