BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY

    MDR report key: 17757405 · Received September 15, 2023

    Report

    Report Number
    8041187-2023-00489
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 29, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868629
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A TREND FOR THE SAFETY SHIELD ACTIVATION FAILURE (CATHETER) FAILURE MODE FOR LOT 2238464 HAS BEEN IDENTIFIED. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO OUR MANUFACTURING PROCESS. ACTIONS TO ADDRESS THIS TREND HAVE BEEN INITIATED AND A MANUFACTURING ROOT CAUSE IS BEING INVESTIGATED FOR THIS FAILURE MODE. BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL OF THE LOT 2238464 FOR THE BD CATHENATM SAFETY IV CATHETER SYSTEM PRODUCT. PRODUCTION RECORDS WERE REVIEWED, AND A NOTABLE PREVENTATIVE MAINTENANCE OCCURRED WHICH COULD BE RELATED TO THE CAUSE OF THIS DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY SAFETY MECHANISM WOULD NOT DISENGAGE FROM THE CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MORE COMPLAINTS COMING FROM THIS SAME HOSPITAL AT *****- INCIDENTS OF CATHETERS NOT SAFETYING PROPERLY FOR LOT 2238462, 2238463 AND 2238464. RESPONSE RECEIVED 06 SEP 2023 864 WAS THE ONLY ONE SUPPOSED TO BE REPORTED. THE OTHERS WERE MADE A MISTAKE BY THE CUSTOMER. ADDT RESPONSE RECEIVED 06 SEP 2023 864 IS REFERRING TO BATCH NUMBER 2238464".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY SAFETY MECHANISM WOULD NOT DISENGAGE FROM THE CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MORE COMPLAINTS COMING FROM THIS SAME HOSPITAL AT INCIDENTS OF CATHETERS NOT SAFETYING PROPERLY FOR LOT 2238462, 2238463 AND 2238464... RESPONSE RECEIVED 06 SEP 2023 864 WAS THE ONLY ONE SUPPOSED TO BE REPORTED. THE OTHERS WERE MADE A MISTAKE BY THE CUSTOMER. ADDT RESPONSE RECEIVED 06 SEP 2023. 864 IS REFERRING TO BATCH NUMBER 2238464."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268757 BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2238464 00382903868629

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown