BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY

    MDR report key: 16763350 · Received April 18, 2023

    Report

    Report Number
    8041187-2023-00162
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868117
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 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 THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY LEAKED CONTRAST MEDIA DURING THE HIGH-PRESSURE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING INJECTIONS OF CONTRAST PRODUCTS (VISCOUS AND THICK) AT A FLOW RATE OF 4-5CC/S, THE OVERPRESSURE CREATED LEADS TO A LEAKAGE OF THE CONTRAST PRODUCT AND THE IMPOSSIBILITY OF MAKING IMAGES AT AN "ARTERIAL" TIME. CONSEQUENCES: LEAKAGE OF STICKY CONTRAST MEDIUM ON OUR FRAGILE MACHINES. FAILED EXAMINATIONS WITH DILUTED CONTRAST PRODUCTS ON A PATIENT WITH MODERATE RENAL INSUFFICIENCY. IMPOSSIBILITY OF KNOWING THE EXACT QUANTITY OF PRODUCT INJECTED. LOSS OF TIME. HAVING TO RE-INJECT PATIENTS TO PLACE A NEW CATHETER".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY LEAKED CONTRAST MEDIA DURING THE HIGH-PRESSURE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "DURING INJECTIONS OF CONTRAST PRODUCTS (VISCOUS AND THICK) AT A FLOW RATE OF 4-5CC/S, THE OVERPRESSURE CREATED LEADS TO A LEAKAGE OF THE CONTRAST PRODUCT AND THE IMPOSSIBILITY OF MAKING IMAGES AT AN "ARTERIAL" TIME. CONSEQUENCES: LEAKAGE OF STICKY CONTRAST MEDIUM ON OUR FRAGILE MACHINES. FAILED EXAMINATIONS WITH DILUTED CONTRAST PRODUCTS ON A PATIENT WITH MODERATE RENAL INSUFFICIENCY. IMPOSSIBILITY OF KNOWING THE EXACT QUANTITY OF PRODUCT INJECTED. LOSS OF TIME. HAVING TO RE-INJECT PATIENTS TO PLACE A NEW CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625263 BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386811 2238458 00382903868117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown