BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ PRO IV CANNULA

    MDR report key: 14189947 · Received April 22, 2022

    Report

    Report Number
    8041187-2022-00213
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    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

    H.6 INVESTIGATION SUMMARY: FIVE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE FIRST TWO PHOTOS, ONE 26G NEOFLON PRO USED SAMPLE WAS OBSERVED WITH THE NEEDLE PIERCED THROUGH THE CATHETER. A BLUNT NEEDLE CANNOT BE SEEN CLEARLY FROM THE PHOTO. THE THIRD AND FOURTH PHOTOS, A PATIENT¿S ARM WAS OBSERVED WITH REDNESS AROUND THE WRIST AREA. THE FIFTH PHOTO SHOWS A TOP WEB OF BATCH 9242213 AND A TOP WEB OF BATCH 0081014. THE TOP WEB OF BATCH 9242213 DOES NOT BELONG TO THE REPORTED COMPLAINT. 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. FROM THE RETURNED PHOTOS, BLOOD WAS OBSERVED IN THE CATHETER. THIS INDICATES A SUCCESSFUL PENETRATION. IT WOULD NOT BE POSSIBLE TO PENETRATE THE VEIN IF THE PRODUCT HAS THE NEEDLE PIERCED THROUGH THE CATHETER. THEREFORE, THE PROBABLE ROOT CAUSE FOR THE REPORTED DEFECT COULD BE DUE TO THE USER HAVING PARTIALLY WITHDRAWING THE NEEDLE FROM THE CATHETER AND UPON REINSERTING THE NEEDLE INTO THE VEIN, THE NEEDLE PIERCED THROUGH THE CATHETER AND DAMAGED THE CATHETER. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS A 100% ONLINE AUTOMATED VISION INSPECTION SYSTEM THAT CAN DETECT AND REJECT PRODUCT NOT MEETING THE LIE DISTANCE REQUIREMENT. IF THE CANNULA PIERCED THROUGH THE CATHETER IN THE MANUFACTURING PROCESS, THE DEFECT PART WOULD BE REJECTED BY THE AUTOMATED VISION INSPECTION SYSTEM AS THE PRODUCT WILL NOT HAVE ANY LIE DISTANCE. THE STERILIZATION RECORDS WERE REVIEWED, AND NO ABNORMALITIES WERE OBSERVED. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO IV CANNULA HAD THE NEEDLE GO THROUGH THE CATHETER DURING INSERTION/HANDLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "DURING INSERTION NURSES REPORT INCREASE PAIN AND REDNESS AROUND INSERTION SITE. TIP OF THE NEEDLE IS BLUNT AND HARD TO INSERT, CANNULA IS TO SOFT AND TO FLEXIBLE. AFTER REMOVAL NURSES REPORT FREQUENT HEMATOMAS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEOFLON¿ PRO IV CANNULA HAD THE NEEDLE GO THROUGH THE CATHETER DURING INSERTION/HANDLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "DURING INSERTION NURSES REPORT INCREASE PAIN AND REDNESS ARROUND INSERTION SITE. TIP OF THE NEEDLE IS BLUNT AND HARD TO INSERT, CANNULA IS TO SOFT AND TO FLEXIBLE. AFTER REMOVEL NURSES REPORT FREQUENT HEMATOMAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795810 BD NEOFLON¿ PRO IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0081014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown