BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 3ML S/SU

    MDR report key: 23616723 · Received November 21, 2025

    Report

    Report Number
    3003916417-2025-00270
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 24, 2025
    Report Date
    December 18, 2025
    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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: IT WAS PERFORMED THE DHR, MAINTENANCE RECORDS AND QUALITY NOTIFICATIONS, AND NO DEVIATIONS ASSOCIATED WITH THE BATCHES IN QUESTION WERE FOUND. UNFORTUNATELY, AS NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER, WE ARE UNABLE TO CONDUCT A DETAILED INVESTIGATION OR DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. BASED ON THE INFORMATION AVAILABLE, WE CANNOT CONFIRM THE VALIDITY OF THE QUERY. OUR MANUFACTURING PROCESS IS VALIDATED AGAINST SPECIFIC RESOURCE CRITERIA, AND THE INCIDENT IDENTIFIED IN THIS CONSULTATION WILL BE MONITORED TO ASSESS TRENDS. AS THIS OCCURRENCE DOES NOT EXCEED THE BATCH'S ACCEPTABLE QUALITY LIMIT (AQL), NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTION IS PROPOSED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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 SYRINGE PLASTIPAK 3ML S/SU HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NFO: (B)(6). WAS ANVISA NOTIFIED? IF SO, WHAT WAS THE NOTIFICATION NUMBER? NO COULD YOU CONFIRM THE DATE OF THE EVENT? BATCH 5078193 OF 3ML SYRINGES THAT AFTER ASPIRATION THE MEDICATION IS COMING BACK", NOT THE FIRST TECHNICAL COMPLAINT WE HAVE RECEIVED ABOUT THIS BATCH, FROM DIFFERENT CUSTOMERS. COULD YOU PROVIDE THE ADDRESS DETAILS, EMAIL ID, AND CONTACT NAME OF THE CUSTOMER INVOLVED IN THIS REPORT? ADDED IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? YES IF SO, PLEASE ANSWER THE QUESTIONS BELOW ADDITIONAL INFORMATION RECEIVED ON 11/03/2025 COULD YOU PLEASE CONFIRM THE DATE OF EVENT? A: 10/24/2025 COULD YOU PLEASE SHARE THE PHOTO SAMPLES RELATED TO THIS EVENT? A: WE DO NOT HAVE ANY PHOTOS. CAN YOU PLEASE CONFIRM THE AFFECTED QUANTITY? A: 15 IT WAS MENTIONED THAT "BATCH 5078193 OF 3ML SYRINGES THAT AFTER ASPIRATION THE MEDICATION IS COMING BACK", NOT THE FIRST TECHNICAL COMPLAINT WE HAVE RECEIVED ABOUT THIS BATCH, FROM DIFFERENT CUSTOMERS". COULD YOU PLEASE CONFIRM WHETHER THE PREVIOUS REPORT WAS SUBMITTED UNDER REFERENCE NUMBER (B)(4)? *IF NO KINDLY PROVIDE THE DETAILS OF THE ANOTHER EVENT? A: THAT'S RIGHT, (B)(4). ADDITIONAL INFORMATION RECEIVED ON 11/18/2025 1. ARE INDIVIDUAL EVENT DATES AVAILABLE FOR EACH OF THE REPORTED OCCURRENCES? IF YES, PLEASE PROVIDE THE DATES. A: (B)(4), (B)(6) 2025 AND (B)(4); (B)(6) 2025. 2. ARE INDIVIDUAL PATIENT IDENTIFIERS AVAILABLE FOR EACH OF THE REPORTED OCCURRENCES? IF YES, PLEASE PROVIDE THE RELEVANT IDENTIFIERS. A: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347675 BD SYRINGE PLASTIPAK 3ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 5078193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown