BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ SYRINGE

    MDR report key: 19267861 · Received May 8, 2024

    Report

    Report Number
    3003916417-2024-00116
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    February 20, 2024
    Report Date
    April 30, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463006615
    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

    DEVICE EVALUATION: SAMPLE RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DEFECTS OR ISSUES OBSERVED. LEAK TEST WAS PERFORMED, IT APPEARS THE NEEDLE IS CLOGGED. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW

    Description of Event or Problem · 0

    POST INVESTIGATION FINDINGS REVEALED THAT THE BD SOLOMED¿ SYRINGE NEEDLE WAS CLOGGED/BLOCKED. INITIAL REPORT FROM CUSTOMER: THE SYRINGE HAS A FAULT IN THE NOZZLE. WHEN IT SUCKS IN THE LIQUID, IT DOESN'T PULL THE LIQUID OUT. *PURPOSE OF USE: IN WHICH PROCEDURE WAS THE MATERIAL BEING OR WOULD IT BE USED? EDIT USED FOR MEDICATION. *MEDICATION/SUBSTANCE INVOLVED IN THE EVENT EDIT BETATRINTA *QUANTITY OF MATERIAL WITH VARIANCE EDIT 1 *IS THE SAMPLE WITH THE DEVIATION AVAILABLE FOR ANALYSIS? EDIT YES *QUANTITY OF SAMPLE WITH DEVIATION AVAILABLE FOR ANALYSIS. 1 *IS THE SAMPLE CONTAMINATED (BODY FLUIDS OR MEDICINES/SOLUTIONS)? EDIT YES YES IF A SAMPLE IS AVAILABLE, IS THE COLLECTION ADDRESS THE SAME AS THE ONE GIVEN AT THE BEGINNING? EDIT YES SAME ADDRESS CAN THE CUSTOMER SEND PHOTOS OF THE MATERIAL FOR ANALYSIS? EDIT YES YES CUSTOMER REQUESTS REPLACEMENT OF MATERIAL WITH DEVIATION? EDIT NO NO *IN WHICH SITUATION WAS THE VARIANCE IDENTIFIED? EDIT DURING HANDLING BY THE PROFESSIONAL TO PREPARE THE PROCEDURE OR MANIPULATE ANY MEDICATION/SUBSTANCE. *WAS THERE ANY DAMAGE TO THE HEALTH OF THE PATIENT OR THE PROFESSIONAL HANDLING THE MATERIAL? EDIT NO *WAS THERE A NEED FOR MEDICAL INTERVENTION? EDIT NO NO *WAS SURGICAL INTERVENTION NECESSARY? EDIT NO *WAS THERE A NEED FOR HOSPITALIZATION OR PROLONGED HOSPITALIZATION? EDIT NO *WAS THERE ANY EXPOSURE TO CHEMICAL/BIOLOGICAL AGENTS (REGARDLESS OF THE USE OF PPE)? EDIT NO *WAS THERE AN ACCIDENTAL NEEDLE PUNCTURE? EDIT NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100801 BD SOLOMED¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN 07891463006615

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown