BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOFLON 24GA 0.7MM OD 19MM L INDIA

    MDR report key: 11656229 · Received April 13, 2021

    Report

    Report Number
    8041187-2021-00273
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 28, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTO SHOWS THE TOP WEB OF THE PRODUCT WITH BATCH 0110733. 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 NEOFLON 24GA 0.7MM OD 19MM L INDIA CANNULA TIP WAS DAMAGED. THIS OCCURRED ON 4 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TIP OF THE CANNULA TEARS OFF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEOFLON 24GA 0.7MM OD 19MM L INDIA CANNULA TIP WAS DAMAGED. THIS OCCURRED ON 4 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TIP OF THE CANNULA TEARS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552951 NEOFLON 24GA 0.7MM OD 19MM L INDIA CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0110733

    Patients

    Seq Age Sex Outcome Treatment
    1