BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SER PLASTIPAK 1ML13X3.8 VAL150

    MDR report key: 18707679 · Received February 14, 2024

    Report

    Report Number
    3003916417-2024-00044
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 11, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    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.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3241852, MAINTENANCE RECORDS WERE FOUND RELATED TO THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SER PLASTIPAK 1ML13X3.8 VAL150 HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: "IN THE RADIO PHARMACY SECTOR, WHEN STARTING THE FRACTIONATION OF THE RADIOPHARMACEUTICAL DOSE, IT WAS OBSERVED THAT THE BD BRAND 'TUBERCULIN' SYRINGE - LOT 324185 - FAB IN (B)(6) 2023, WAS DAMAGED. WITH THE NEEDLE 'DISCONNECTED FROM THE BASE'."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225191 BD SER PLASTIPAK 1ML13X3.8 VAL150 SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 3241852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown