BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 5ML S/SU

    MDR report key: 23392856 · Received October 27, 2025

    Report

    Report Number
    3003916417-2025-00227
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 12, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN; THEREFORE, DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 5ML S/SU PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS THE PROBLEM WITH THE MATERIAL? IT WAS REPORTED THAT THE CUSTOMER BUYS 30 UNITS PER MONTH AND NOTICES THAT OCCASIONALLY THE PLUNGER BREAKS WHEN PULLED. MATERIAL DESCRIPTION: PLASTIPAK 5ML LL SYRINGE. CATALOG: 990175. BATCH/SERIAL NUMBER: SINGLE PURCHASE. DATE OF OCCURRENCE: THE CUSTOMER PURCHASES AROUND 30 UNITS PER MONTH. WHICH PART/COMPONENT/PIECE OF THE PRODUCT IS INVOLVED IN THE COMPLAINT? PLUNGER. INTENDED USE: IN WHICH PROCEDURE WAS THE MATERIAL BEING OR WOULD BE USED? THE CUSTOMER PERFORMS HEMOTHERAPY, USING THE SYRINGE TO DRAW BLOOD AND INJECT IT INTO THE MUSCLE. MEDICATION/SUBSTANCE INVOLVED IN THE OCCURRENCE. THE CUSTOMER DOES NOT MENTION THE NAME/SUBSTANCE. QUANTITY OF MATERIAL WITH DEVIATION 2. IS THE SAMPLE THAT PRESENTED THE DEVIATION AVAILABLE FOR ANALYSIS? YES. QUANTITY OF SAMPLE WITH DEVIATION AVAILABLE FOR ANALYSIS. 2. IS THE SAMPLE CONTAMINATED (BODY FLUIDS OR MEDICATIONS/SOLUTIONS)? YES. IF A SAMPLE IS AVAILABLE, IS THE COLLECTION ADDRESS THE SAME AS THE ONE PROVIDED AT THE BEGINNING? SAME ADDRESS. CAN THE CLIENT SEND PHOTO SAMPLES OF THE MATERIAL FOR ANALYSIS? YES. DOES THE CLIENT REQUEST REPLACEMENT OF THE MATERIAL WITH DEVIATION? YES. IN WHAT SITUATION WAS THE DEVIATION IDENTIFIED? 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 WHO HANDLED THE MATERIAL? NO. WAS MEDICAL INTERVENTION NECESSARY? NO. WAS SURGICAL INTERVENTION NECESSARY? NO. WAS HOSPITALIZATION OR PROLONGED HOSPITALIZATION NECESSARY? NO. WAS THERE EXPOSURE TO CHEMICAL/BIOLOGICAL AGENTS (REGARDLESS OF PPE USE)? NO. WAS THERE ACCIDENTAL NEEDLE STICK INJURY? NO. DID THE EVENT LEAD TO DEATH? NO. WAS THERE A SECOND MATERIAL AND/OR INCIDENT REPORTED? NO..

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794730 BD SYRINGE PLASTIPAK 5ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown