BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY

    MDR report key: 16301572 · Received February 4, 2023

    Report

    Report Number
    8041187-2023-00047
    Event Type
    Malfunction
    Date Received
    February 4, 2023
    Date of Event
    January 13, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868070
    PMA / PMN Number
    K201717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2022963. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025. DEVICE MANUFACTURE DATE: 22-JAN-2022. MEDICAL DEVICE LOT #: 2110513. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025. DEVICE MANUFACTURE DATE: 20-APR-2022. 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 1 BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY EACH FROM LOTS 2022963 AND 2110513 SPLIT APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BIOMEDICAL ENGINEER RECEIVED NOTIFICATION THAT ON TWO OCCASIONS, RNS COMPLAINED ABOUT CATHENA IV CATHETER "SPLITTING""

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY EACH FROM LOTS 2022963 AND 2110513 SPLIT APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BIOMEDICAL ENGINEER RECEIVED NOTIFICATION THAT ON TWO OCCASIONS, RNS COMPLAINED ABOUT CATHENA IV CATHETER "SPLITTING"".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137164 BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386807 SEE H10 00382903868070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown