BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L

    MDR report key: 18213010 · Received November 27, 2023

    Report

    Report Number
    2243072-2023-02097
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    October 2, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903932221
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AS NO SAMPLE AND NO PHOTO WERE RETURNED, FURTHER INVESTIGATION CANNOT BE PERFORMED. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED PER CONTROL PLAN, CP-54 DURING PRODUCTION. DHR WAS REVIEWED AND NO ABNORMALITY WAS REPORTED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT IN THE PAST 12 MONTHS. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT TREND WOULD BE MONITORED AND COMPLAINT WILL BE REOPENED WHEN SAMPLE IS RETURNED.

    Additional Manufacturer Narrative · 0

    FROM THE RETURNED PHOTOS, BLOOD WAS OBSERVED IN THE CATHETER FRONT END. THIS INDICATES A SUCCESSFUL PENETRATION. IT WOULD NOT BE POSSIBLE TO USE THE PRODUCT IF THE NEEDLE HAS PIERCED THROUGH THE CATHETER. THE PROBABLE ROOT CAUSE FOR THE REPORTED DEFECT COULD BE DUE TO USER HAD PARTIALLY WITHDRAWN THE NEEDLE FROM THE CATHETER AND REINSERTING THE NEEDLE INTO THE CATHETER, THE NEEDLE PIERCE THROUGH THE CATHETER AND DAMAGE THE CATHETER. PRODUCT IFU IS CLEARLY STATED THAT NEVER REINSERT THE NEEDLE INTO THE CATHETER. HOWEVER, AS IT IS NOT POSSIBLE TO CONFIRM HOW THE PRODUCT HAS BEEN USED, THE ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WAS PERFORMED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT. COMPLAINT TREND WOULD BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L BROKE WHEN PVK IS INSTALLED, THE PVK BREAKS. PVK WAS PLACED IN THE VEIN WITHOUT ANY PROBLEMS, AND THERE WAS RUNNING BACK. JUST WHEN PVK WAS TO BE CARRIED FORWARD, THERE WAS RESISTANCE. UT REMOVES THE PVC AND CAN SEE THAT THE PVC / PLASTIC PIPE IS BROKEN. BRIEFLY DESCRIBE THE INCIDENT * PVK ERROR EVENT DATE (DD-MM-YYYY) * (B)(6) 2023 DETAILED DESCRIPTION OF THE INCIDENT WHEN PVK IS INSTALLED, THE PVK BREAKS. PVK WAS PLACED IN THE VEIN WITHOUT ANY PROBLEMS, AND THERE WAS RUNNING BACK. JUST WHEN PVK WAS TO BE CARRIED FORWARD, THERE WAS RESISTANCE. UT REMOVES THE PVC AND CAN SEE THAT THE PVC / PLASTIC PIPE IS BROKEN. CONSEQUENCE OF THE INCIDENT * NONE, AS THE INCIDENT WAS AVOIDED WHERE DID THE INCIDENT HAPPEN? HOSPITAL OR INSTITUTION.

    Description of Event or Problem · 0

    WHEN PVK IS INSTALLED, THE PVK BREAKS. PVK WAS PLACED IN THE VEIN WITHOUT ANY PROBLEMS, AND THERE WAS RUNNING BACK. JUST WHEN PVK WAS TO BE CARRIED FORWARD, THERE WAS RESISTANCE. UT REMOVES THE PVC AND CAN SEE THAT THE PVC / PLASTIC PIPE IS BROKEN. BRIEFLY DESCRIBE THE INCIDENT: PVK ERROR. EVENT DATE (DD-MM-YYYY) 02/10/2023. DETAILED DESCRIPTION OF THE INCIDENT WHEN PVK IS INSTALLED, THE PVK BREAKS. PVK WAS PLACED IN THE VEIN WITHOUT ANY PROBLEMS, AND THERE WAS RUNNING BACK. JUST WHEN PVK WAS TO BE CARRIED FORWARD, THERE WAS RESISTANCE. UT REMOVES THE PVC AND CAN SEE THAT THE PVC / PLASTIC PIPE IS BROKEN. CONSEQUENCE OF THE INCIDENT: NONE, AS THE INCIDENT WAS AVOIDED. WHERE DID THE INCIDENT HAPPEN? HOSPITAL OR INSTITUTION.

    Description of Event or Problem · 0

    WHEN PVK IS INSTALLED, THE PVK BREAKS. PVK WAS PLACED IN THE VEIN WITHOUT ANY PROBLEMS, AND THERE WAS RUNNING BACK. JUST WHEN PVK WAS TO BE CARRIED FORWARD, THERE WAS RESISTANCE. UT REMOVES THE PVC AND CAN SEE THAT THE PVC / PLASTIC PIPE IS BROKEN. BRIEFLY DESCRIBE THE INCIDENT PVK ERROR. EVENT DATE (B)(6) 2023. DETAILED DESCRIPTION OF THE INCIDENT WHEN PVK IS INSTALLED, THE PVK BREAKS. PVK WAS PLACED IN THE VEIN WITHOUT ANY PROBLEMS, AND THERE WAS RUNNING BACK. JUST WHEN PVK WAS TO BE CARRIED FORWARD, THERE WAS RESISTANCE. UT REMOVES THE PVC AND CAN SEE THAT THE PVC / PLASTIC PIPE IS BROKEN. CONSEQUENCE OF THE INCIDENT NONE, AS THE INCIDENT WAS AVOIDED WHERE DID THE INCIDENT HAPPEN? HOSPITAL OR INSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499137 BD VENFLON PRO SAFETY 22GA 0.9MM OD 25MM L INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2233080 00382903932221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown