BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 10ML S/SU

    MDR report key: 22560605 · Received July 21, 2025

    Report

    Report Number
    3003916417-2025-00136
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 27, 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

    WE CONDUCTED AN ANALYSIS OF THE LOT HISTORY (DHR) AND REVIEWED THE ASSOCIATED QUALITY NOTIFICATIONS. NO RECORDS DIRECTLY RELATED TO THE REPORTED DEFECT WERE FOUND FOR THE LOT IN QUESTION. HOWEVER, WE IDENTIFIED A MAINTENANCE ORDER (NO. (B)(4)) THAT MAY BE ASSOCIATED WITH THE INCIDENT. IN THE PHOTO PROVIDED, THE BREAKAGE OF THE PLUNGER ROD IS CLEARLY VISIBLE, WHICH ALIGNS WITH THE FAILURE RECORDED IN THE ROD PICKER DISK. THE EQUIPMENT EXPERIENCED ROD BREAKAGE DURING THE SYRINGE ASSEMBLY PROCESS, AND ACCORDING TO THE MAINTENANCE ORDER, THE DISK WAS REPLACED AND MONITORED. THEREFORE, BD CONFIRMS AND REPRODUCES THE COMPLAINT. THE ASSEMBLY PROCESS IS AUTOMATED, AND THE SYRINGE WITH THE BROKEN ROD WAS ASSEMBLED AND PASSED THROUGH INSPECTION WITHOUT BEING REJECTED OR NOTICED BY THE OPERATOR. THIS OCCURRED BECAUSE THE TYPE OF FAILURE DID NOT GENERATE CLEAR VISUAL INDICATORS DETECTABLE BY THE EXISTING CONTROLS. CURRENTLY, CONTROLS FOR DETECTING THIS TYPE OF INCIDENT INCLUDE MANUAL VISUAL INSPECTIONS PERFORMED BY SAMPLING EVERY HOUR DURING THE PACKAGING CYCLE. THERE IS NO AUTOMATED VISION SYSTEM IN PLACE TO IDENTIFY THIS SPECIFIC TYPE OF DAMAGE TO THE PLUNGER, WHICH LIMITS DETECTION CAPABILITY IN ISOLATED CASES LIKE THIS. THIS RISK IS ADDRESSED IN THE FMEA ANALYSIS AND IS IN COMPLIANCE WITH PRODUCT SPECIFICATIONS. AS THIS IS THE FIRST COMPLAINT RECORDED FOR THE LOT, AND IT DOES NOT EXCEED THE ACCEPTABLE QUALITY NOTIFICATION (NQA) LIMIT, THE INCIDENT WILL BE MONITORED FOR TREND EVALUATION, AND NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME. PACKAGE DAMAGE UPON ANALYSIS, WE VERIFIED THAT THE PACKAGING WAS DAMAGED DUE TO THE COMPROMISED PLUNGER ROD, WHICH RESULTED IN PUNCTURING THE PACKAGE. BD CONFIRMS THE REPORTED COMPLAINT. DURING THE ASSEMBLY PROCESS, VISUAL INSPECTIONS BY SAMPLING ARE PERFORMED EVERY TWO HOURS. HOWEVER, THERE IS NO AUTOMATED VISION SYSTEM TO DETECT SPECIFIC FAILURES SUCH AS ROD BREAKAGE. THE INSPECTION IS CONDUCTED MANUALLY, AND THE TYPE OF DAMAGE PRESENTED MAY NOT BE EASILY NOTICEABLE DEPENDING ON ITS POSITION OR EXTENT. FOLLOWING THE INCIDENT, THE PRODUCTION TEAM WAS NOTIFIED TO REINFORCE ATTENTION DURING VISUAL INSPECTIONS AND ENSURE INCREASED VIGILANCE REGARDING THIS TYPE OF OCCURRENCE. WE EMPHASIZE THAT THIS IS AN ISOLATED DEFECT, CAUSED BY A SPECIFIC CONDITION OF THE ROD. AS THIS IS THE FIRST COMPLAINT RECORDED FOR THE BATCH, AND IT DOES NOT EXCEED THE ACCEPTABLE QUALITY NOTIFICATION (NQA) LIMIT, THE INCIDENT WILL BE MONITORED FOR TREND EVALUATION, AND NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED 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 PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 10ML S/SU PACKAGING WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 10ML SYRINGE WITH A MANUFACTURING DEFECT WAS RECEIVED IN THE QUOTA, WITH A PLASTIC PROTRUSION STICKING OUT OF THE STERILE PACKAGING, THE MATERIAL WAS SENT TO QUARANTINE, AND A TECHNICAL COMPLAINT NOTIFICATION WAS OPENED. ADDITIONAL INFORMATION RECEIVED ON JULY 1, 2025 COULD YOU SHARE THE PHOTO SAMPLES OF THE REPORTED EVENT? HAS ANVISA BEEN NOTIFIED? IF SO, WHAT IS THE NOTIFICATION NUMBER? - THERE WAS NO NOTIFICATION TO ANVISA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737083 BD SYRINGE PLASTIPAK 10ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4297841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown