BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 22X1-1/4 ECLIPSE

    MDR report key: 19715801 · Received July 10, 2024

    Report

    Report Number
    3003916417-2024-00175
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    May 17, 2024
    Report Date
    August 2, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    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

    SAMPLE NEEDLE AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DEFECTS WERE OBSERVED ON THE NEEDLE OR ANY OTHER COMPONENTS OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED, DRAWING LIQUID FROM A VIAL WITH THE NEEDLE ALONG WITH A SAMPLE SYRINGE ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2153557, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 22X1-1/4 ECLIPSE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: WE RECEIVED A COMPLAINT FROM A MARKET IN WHICH THE PATIENT THE MOMENT HE WENT TO APPLY IT TO THE PART WHERE THE NEEDLE FITS, EVERYTHING STARTED LEAKING THROUGH THE GLUE ON THE FOOT OF THE NEEDLE. AS DETAILED IN THE COMPLAINT, THE PRODUCT WAS LOST, CAUSING DISSATISFACTION AND DELAYING THE PATIENT'S TREATMENT. ADDITIONAL INFORMATION RECEIVED: COULD YOU CONFIRM THAT THE SAMPLE IS AVAILABLE FOR ANALYSIS? YES. IF SO, PLEASE INFORM US OF THE FOLLOWING SO THAT WE CAN SCHEDULE THE COLLECTION CUSTOMER SHARED THE INFORMATION AND ADDED IN ATTACHMENTS INFORM WHETHER THE SAMPLE IS CONTAMINATED, AND IF SO, BY WHICH SUBSTANCE: R: AS THE DEVIATION WAS NOTICED AT THE TIME OF APPLICATION, THE SUBSTANCE IS PROBABLY FROM THE PRODUCT INVOLVED IN THE COMPLAINT ¿ DIPROSPAN HYPAK. WHAT TYPE OF SYRINGE WAS USED? IS IT A BD SYRINGE? A: HYPAK SYRINGE. HYPAK PRODUCT DATA SHARED. WERE YOU ABLE TO COMPLETE THE PROCEDURES USING A DIFFERENT NEEDLE? A: NOT INFORMED. HOWEVER, THE CUSTOMER WAS REIMBURSED. WAS THERE ANY VISIBLE DAMAGE NOTED ON THE NEEDLE BEFORE THE PROCEDURE? A: WE ONLY HAVE THE INFORMATION ATTRIBUTED IN THE CALL REPORT, IN WHICH THE INCIDENT WAS IDENTIFIED DURING HANDLING. COULD YOU CONFIRM THAT THE EVENT DATE IS JUNE 17, 2024? IF NOT, PLEASE SHARE THE CORRECT DATE. A: PRODUCT PURCHASE DATE: 05/16/2024 // CALL DATE: 05/17/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142794 BD NEEDLE 22X1-1/4 ECLIPSE NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 2153557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown