BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY

    MDR report key: 10394391 · Received August 11, 2020

    Report

    Report Number
    8041187-2020-00480
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 12, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868087
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. 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 QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT A BLOOD LEAKAGE WAS DRIPPING OUT THE BACK OF THE CATHETER. AHS MDIP REPORT INCIDENT OR PROBLEM INFORMATION AHS MDIP REFERENCE NUMBER (ID): 5012 DATE OF INCIDENT (YYYY-MM-DD): (B)(6). 2020. SITE NAME/LOCATION: CARDSTON EMS LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): NO INCIDENT DETAILS: WAS USING THE BD CATHENA SAFETY IV CATHETER THAT IS BLOODLESS AS PER AHS POLICY AND PROCEDURE. ONCE THE SHARP WAS REMOVED BLOOD CONTINUED TO FLOW OUT OF THE BACK OF CATHETER, DRIPPING ON TO FLOOR AND MY UNIFORM AND ALSO DOWN THE PATIENT'S ARM. WHO WAS AFFECTED? PATIENT DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY WINGED WITH MULTIGUARD 18GAX1.25IN CATHENA MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: (B)(4). SERIAL OR LOT NUMBER: 8116292 SUPPLIER: THE STEVENS COMPANY LTD SUPPLIER CATALOGUE NUMBER: 333-386808 WAS THE DEVICE RETAINED? NO. INVESTIGATION REQUEST EXPECTED TYPE OF INVESTIGATION: LOT REVIEW, REPORT HISTORY/TREND ANALYSIS".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT A BLOOD LEAKAGE WAS DRIPPING OUT THE BACK OF THE CATHETER. AHS MDIP REPORT INCIDENT OR PROBLEM INFORMATION AHS MDIP REFERENCE NUMBER (ID): 5012 DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2020 SITE NAME/LOCATION: (B)(6). LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT (B)(6) OPTIONAL REPORT TO (B)(6): (B)(4): NO. INCIDENT DETAILS: WAS USING THE BD CATHENA SAFETY IV CATHETER THAT IS BLOODLESS AS PER (B)(6) POLICY AND PROCEDURE. ONCE THE SHARP WAS REMOVED BLOOD CONTINUED TO FLOW OUT OF THE BACK OF CATHETER, DRIPPING ON TO FLOOR AND MY UNIFORM AND ALSO DOWN THE PATIENT'S ARM. WHO WAS AFFECTED? PATIENT. DEVICE INFORMATION. DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY WINGED WITH MULTIGUARD 18 GA X 1.25 IN CATHENA MANUFACTURER: (B)(4). MANUFACTURER CODE/MODEL: 386808 SERIAL OR LOT NUMBER: 8116292, SUPPLIER: THE STEVENS COMPANY LTD SUPPLIER CATALOGUE NUMBER: 333-386808 WAS THE DEVICE RETAINED? NO. INVESTIGATION REQUEST: EXPECTED TYPE OF INVESTIGATION: LOT REVIEW, REPORT HISTORY/TREND ANALYSIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858651 BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386808 8116292 00382903868087

    Patients

    Seq Age Sex Outcome Treatment
    1 Other