BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH 22GA X 1,00IN 0,9 X 25MM

    MDR report key: 12816930 · Received November 15, 2021

    Report

    Report Number
    9610048-2021-00155
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 14, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WHEN USING THE BD ANGIOCATH 22GA X 1,00IN 0,9 X 25MM, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I INFORM YOU THAT WE HAVE IDENTIFIED TRACES OF DIRT INSIDE THE CAP OF A PERIPHERAL INTRAVENOUS CATHETER 22GAX1.00 LOT 0133784 VALIDITY 05/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ANGIOCATH 22GA X 1,00IN 0,9 X 25MM, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I INFORM YOU THAT WE HAVE IDENTIFIED TRACES OF DIRT INSIDE THE CAP OF A PERIPHERAL INTRAVENOUS CATHETER 22GAX1.00 LOT 0133784 VALIDITY 05/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709208 BD ANGIOCATH 22GA X 1,00IN 0,9 X 25MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 0133784

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown