BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 X.45 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER, INJECTION VALVE

    MDR report key: 6731016 · Received July 21, 2017

    Report

    Report Number
    8041187-2017-00052
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 28, 2017
    Report Date
    September 21, 2017
    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
    GM
    Reporter Occupation
    HOME HEALTH AIDE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 3 USED SAMPLES (1 CONTAMINATED BROKEN CATHETER SAMPLE, 2 OPEN USED SAMPLES WITHOUT CANNULA) AND 1 REPRESENTATIVE SAMPLE WERE RETURNED FOR THE INVESTIGATION OF THIS COMPLAINT. SAMPLES RETURNED : USED SAMPLE (SAMPLE #1): BROKEN CATHETER WAS OBSERVED ON ACTUAL SAMPLE #1. THE BROKEN CATHETER COULD HAVE PROBABLY BEEN CUT BY SHARP OBJECT. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD HAVE CAUSED THIS NONCONFORMANCE. 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. ACTUAL SAMPLE #1 (BROKEN CATHETER). USED SAMPLE (SAMPLE #2 AND SAMPLE #3): SAMPLE #2 AND SAMPLE #3 WERE SUBJECTED TO VISUAL INSPECTION ON THE CATHETER. SAMPLE #2 AND SAMPLE #3 WERE ALSO SUBJECTED TO CATHETER ADAPTOR LEAK TEST. BOTH SAMPLE #2 AND SAMPLE #3 PASSED THE VISUAL INSPECTION AND CATHETER ADAPTOR LEAK TEST. REPRESENTATIVE SAMPLE (SAMPLE #4): SAMPLE #4 WAS SUBJECTED TO VISUAL INSPECTION ON THE CATHETER. SAMPLE #4 WAS ALSO SUBJECTED TO CATHETER ADAPTOR LEAK TEST. SAMPLE #4 PASSED THE VISUAL INSPECTION AND CATHETER ADAPTOR LEAK TEST. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7051422. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. INVESTIGATION CONCLUSION: BROKEN CATHETER WAS OBSERVED ON ACTUAL SAMPLE #1. THE BROKEN CATHETER COULD HAVE PROBABLY BEEN CUT BY SHARP OBJECT. THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD HAVE CAUSED THIS NONCONFORMANCE. SAMPLE #2, SAMPLE #3 AND SAMPLE #4 PASSED THE VISUAL INSPECTION AND CATHETER ADAPTOR LEAK TEST. THEREFORE, THE NONCONFORMANCE CANNOT BE DETERMINED. ROOT CAUSE DESCRIPTION: THE BROKEN CATHETER COULD HAVE PROBABLY BEEN CUT BY SHARP OBJECT. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD HAVE CAUSED THIS NONCONFORMANCE. THERE IS AN AUTOMATED VISION INSPECTION TO INSPECT 100% OF THE PRODUCT FOR THE LIE DISTANCE. A BROKEN CATHETER WILL AUTOMATICALLY BE REJECTED AS THE LIE DISTANCE WILL BE OUT OF SPECIFICATION. THEREFORE, THIS REPORTED NONCONFORMANCE COULD HAVE OCCURRED OUT OF THE MANUFACTURING FACILITIES.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A NURSE WAS PLACING A 18 X.45 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER, THE CATHETER WAS TORN OFF DURING MANIPULATION. THE CATHETER REMAINED IN THE PATIENT AND SURGICAL INTERVENTION WAS PERFORM TO REMOVE THE REMAINING FRAGMENTS. AS REPORTED ON (B)(6) 2017, THE PATIENT WAS STILL RECOVERING. NO FURTHER INFORMATION IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512544 18 X.45 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER, INJECTION VALVE INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7051422

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention