BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ IV CANNULA

    MDR report key: 16212648 · Received January 19, 2023

    Report

    Report Number
    2243072-2023-00045
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    December 5, 2022
    Report Date
    April 4, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE FOUR PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS OF A VENFLON 2 PNK 20GA IV CANNULA FROM AN UNKNOWN LOT NUMBER REGARDING ITEM NUMBER 391452 WITH THE REPORTED ISSUE OF PACKAGE DAMAGED. BD COULD NOT INVESTIGATE THE COMPLAINTS WITHOUT LOT NUMBER THE PHOTOGRAPHS WERE ANALYZED BUT WITH LIMITED INFORMATION NOTHING COULD BE CONCLUDED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL, INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 07-FEB-2023. H6: INVESTIGATION SUMMARY SAMPLES AND PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PICTURES AND INSPECT THE RETURNED SAMPLES FOR THE REPORTED ISSUE OF BROKEN CATHETER FROM LOT # UNKNOWN PRODUCT # 391452. THE INVESTIGATING TEAM DID NOT USE THE RETENTION SAMPLES DUE TO UNKNOWN LOT NO. FOR INVESTIGATING THE REPORTED DEFECT. THE ORIGINAL CONTAMINATED SAMPLE WAS USED TO INVESTIGATE THE COMPLAINT OF BROKEN CATHETER AND IT WAS FOUND THAT THE SAMPLE DOES NOT SHOW BROKEN CATHETER IT SEEMS CUT THE CATHETER IN IT. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. THE PTFE TUBE IS FIRMLY ATTACHED WITH THE CATHETER ADAPTOR & ITS PULL FORCE IS MEASURED & DOCUMENTED IN EVERY LOT. THE PROBABLE ROOT CAUSE APPEARS TO BE CATHETER WAS NOT INSERTED OR WITHDRAWN IN THE PRESCRIBED MANNER DUE TO WHICH IT GOT DIFFICULT TO WITHDRAW IT FROM THE VEIN. THE CATHETER MIGHT BE THEREFORE CUT WITH A SHARP BLADE OR KNIFE DURING REMOVAL OF THE CATHETER. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ IV CANNULA BROKE OFF INTO THE PATIENT'S ARM AFTER BEING PLACED, AND AN INCISION HAD TO MADE TO REMOVE THE BROKEN PIECE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "VENFLON BROKE OFF IN PATIENT'S ARM, PATIENT WAS JUST LYING STILL IN BED, NO RUNNING IV. PLASTIC TUBE LEFT SUBCUTANEOUSLY IN MS.'S ARM. MS HAD TO GET AN INCISION BY PHYSICIAN ASSISTANT FROM CHI SO THIS PLASTIC TUBE OF VENFLON CAN BE REMOVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ IV CANNULA BROKE OFF INTO THE PATIENT'S ARM AFTER BEING PLACED, AND AN INCISION HAD TO MADE TO REMOVE THE BROKEN PIECE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "VENFLON BROKE OFF IN PATIENT'S ARM, PATIENT WAS JUST LYING STILL IN BED, NO RUNNING IV. PLASTIC TUBE LEFT SUBCUTANEOUSLY IN MS.'S ARM. MS HAD TO GET AN INCISION BY PHYSICIAN ASSISTANT FROM CHI SO THIS PLASTIC TUBE OF VENFLON CAN BE REMOVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ IV CANNULA BROKE OFF INTO THE PATIENT'S ARM AFTER BEING PLACED, AND AN INCISION HAD TO MADE TO REMOVE THE BROKEN PIECE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "VENFLON BROKE OFF IN PATIENT'S ARM, PATIENT WAS JUST LYING STILL IN BED, NO RUNNING IV. PLASTIC TUBE LEFT SUBCUTANEOUSLY IN MS.'S ARM. MS HAD TO GET AN INCISION BY PHYSICIAN ASSISTANT FROM CHI SO THIS PLASTIC TUBE OF VENFLON CAN BE REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113706 BD VENFLON¿ IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention