BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BRAZIL

    MDR report key: 21481144 · Received February 27, 2025

    Report

    Report Number
    1911916-2025-00161
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903035526
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED SYRINGES ARE NOT RETAINING THE MEDICATION. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH NO PACKAGING BLISTER; THE PLUNGER ROD IS EITHER HALFWAY OR ALL THE WAY DOWN. THERE ARE DROPLETS OF A CLEAR SOLUTION PAST THE STOPPER. ONE PHOTO ALSO SHOWS A PACKAGING BLISTER TOP WEB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED 303552, LOT 4122736. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    DESCRIPTION/EVENT DETAILS: SOME UNITS OF THIS BATCH OF SYRINGES ARE NOT FULLY RETAINING THE MEDICATION IN THE CYLINDER PART, CAUSING LEAKAGE ALONG THE FLANGE. AS WE HANDLE CHEMOTHERAPY DRUGS, THIS IS A VERY CRITICAL ISSUE. AT WHAT POINT WAS THE OCCURRENCE WITH THE PRODUCT IDENTIFIED (BEFORE STARTING THE PROCEDURE, DURING HANDLING OF THE PRODUCT BY THE PROFESSIONAL/USER, DURING USE ON THE PATIENT OR AFTER USE ON THE PATIENT)? DURING THE HANDLING OF THE PRODUCT BY THE PROFESSIONAL. HAS THERE BEEN ANY HARM TO THE PATIENT, HEALTH PROFESSIONAL, USER OR OTHER? (GIVE DETAILS). SPILLAGE OF CHEMOTHERAPY ON THE SAFETY BOOTH BENCH AND SAFETY OVERALLS. WHEN THIS TYPE OF SITUATION OCCURS, IT IS NECESSARY TO STOP THE DILUTION PROCESS, CLEAN THE CABIN AND CHANGE INTO SAFETY OVERALLS AND STERILE GLOVES TO RESTART THE PROCESS. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION BECAUSE OF WHAT HAPPENED (IMAGING TESTS, SURGERY, ADMINISTRATION OF MEDICATION, ETC.)? (GIVE DETAILS). NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115310 SYRINGE 50ML LL BRAZIL SYRINGE, PISTON FMF BECTON DICKINSON 4122736 00382903035526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown