BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER

    MDR report key: 15621149 · Received October 18, 2022

    Report

    Report Number
    8041187-2022-00599
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 8, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE FIRST PHOTO, A TOP WEB OF CATALOG 393226 AND BATCH 2022986 WAS OBSERVED. FROM THE SECOND PHOTO, A 18G VENFLON PRO SAFETY PRODUCT WITH A BROKEN CANNULA REMAINED IN THE CATHETER AND THE OTHER PORTION OF THE CANNULA WAS ATTACHED TO THE NEEDLE HUB. FROM THE THIRD PHOTO, A NEEDLE HUB WITH A BROKEN CANNULA WITH CURVED EDGES WAS OBSERVED. FINALLY, A BROKEN CANNULA REMAINS IN THE CATHETER WAS OBSERVED IN THE FOURTH PHOTO. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE RETURNED PHOTOS, CURVED EDGES WERE OBSERVED ON THE BROKEN EDGE OF THE CANNULA. THIS SUGGESTS THAT MATERIAL NECKING HAS OCCURRED WHICH IS LIKELY CAUSED BY THE CANNULA BEING BENT BEYOND THE ULTIMATE STRENGTH THAT THE CANNULA CAN WITHSTAND. THIS EVENTUALLY LED TO THE BROKEN CANNULA. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS NO PROCESS DURING MANUFACTURING THAT WOULD CAUSE THE CANNULA TO BEND TO SUCH EXTENT THAT WOULD BREAK THE CANNULA. IN ADDITION, IF THE NEEDLE WAS BENT, IT IS NOT POSSIBLE TO ASSEMBLE THE PROTECTION TUBE. THEREFORE, THE REPORTED NONCONFORMANCE IS NOT CAUSED BY THE MANUFACTURING PROCESS. A SIMULATION WAS PERFORMED TO SIMULATE THE DEFECT. A 18G VENFLON PRO SAFETY SAMPLE WAS BENT AT ABOUT 90 DEGREES IN THE UNIT PACKAGING. THE SAMPLE WAS THEN REMOVED FROM THE PACKAGE AND INSPECTED. A SIMILAR DEFECT WAS REPLICATED. THEREFORE, THE PROBABLE ROOT CAUSE FOR THE BROKEN CANNULA COULD BE DUE TO THE MANIPULATION OF THE PRODUCT OR INAPPROPRIATE STORAGE OF THE PRODUCT SUCH AS OVER PACKING THE SHELF WHICH RESULTED IN THE PRODUCT TO BEND. HOWEVER, AS IT IS NOT POSSIBLE TO CONFIRM HOW THE PRODUCT WAS BEING HANDLED, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON PRO SAFETY VENOUS INDWELLING CATHETER EXPERIENCED NEEDLE BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN AT A CT WARD WAS ABOUT TO INSERT THE VENFLON INTO A PATIENT, AND DURING INSERTION THE PERSONNEL THOUGHT THAT THE NEEDLE FELT A BIT STRANGE. THE PERSONNEL MANAGED TO INSERT THE VENFLON INTO THE VEIN, BUT WHEN TAKING OUT THE NEEDLE IT WAS BROKEN IN TWO. THE PERSONNEL THEREFORE REMOVED THE ENTIRE VENFLON FROM VEIN AND NOTICED THAT THE REST OF THE NEEDLE WAS INSIDE THE PLASTIC TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER EXPERIENCED NEEDLE BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN AT A CT WARD WAS ABOUT TO INSERT THE VENFLON INTO A PATIENT, AND DURING INSERTION THE PERSONNEL THOUGHT THAT THE NEEDLE FELT A BIT STRANGE. THE PERSONNEL MANAGED TO INSERT THE VENFLON INTO THE VEIN, BUT WHEN TAKING OUT THE NEEDLE IT WAS BROKEN IN TWO. THE PERSONNEL THEREFORE REMOVED THE ENTIRE VENFLON FROM VEIN AND NOTICED THAT THE REST OF THE NEEDLE WAS INSIDE THE PLASTIC TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379057 BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2022986

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown