BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 19097517 · Received April 12, 2024

    Report

    Report Number
    3003152976-2024-00228
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    April 5, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION/CORRECTION: CORRECTION: MULTIPLE LOTS WERE INITIALLY REPORTED, FOLLOWING SUBMISSION OF INITIAL MDR, IT WAS IDENTIFIED THESE LOTS WAS NOT INCLUDED ON INITIAL REPORT. ADDITIONAL IMPACTED LOTS: LOT: 2401031 BATCH CREATION DATE: 2024-01-02, BATCH EXPIRATION DATE: 2028-12-31. LOT: 2401032 BATCH CREATION DATE: 2024-01-02 , BATCH EXPIRATION DATE: 2028-12-31. LOT: 2209022 BATCH CREATION DATE: 2022-08-30 , BATCH EXPIRATION DATE: 2027-08-31. DEVICE EVALUATION: TWO PHOTOS, ALONG WITH FOURTEEN SAMPLES FROM LOT 2401032 AND FIVE SAMPLES FROM LOT 2401031, WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NO PHYSICAL SAMPLES HAVE BEEN RECEIVED FOR LOTS 2209022 AND 2303018. THROUGH VISUAL INSPECTION OF THE PHOTOS, SILICONE IS OBSERVED WITHIN THE SYRINGE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO HELP FACILITATE MOVEMENT OF THE PLUNGER AND STOPPER. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR REPORTED LOTS 2401031, 2401032, 2209022, AND 2303018, AND WERE FOUND TO BE WITHIN SPECIFICATION. THE SAMPLES UNDERWENT THESE SAME TESTS AND FOUND ONE SYRINGE FROM LOT 2401032 WAS SLIGHTLY ABOVE OUR SPECIFIED LIMITS, HOWEVER, IT WAS VERIFIED THE QUANTITY WAS STILL COMPLIANT WITH ISO-7886-1. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 2401031, 2401032, 2209022, AND 2303018, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF EACH REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO EVIDENCE OF SILICONE WAS OBSERVED WITHIN THE SYRINGES AND SILICONE CONTENT TESTING CONFIRMED THE PRODUCT MET REQUIRED SPECIFICATIONS. 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, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE FOUND. BASED ON OUR INVESTIGATION, A ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. GIVEN THE VISCOSITY OF THE LUBRICANT, IT IS POSSIBLE TO SEE EVIDENCE OF IT WHEN MOVING THE STOPPER FROM BEING FULLY SEATED AT THE TOP OF THE SYRINGE. A PROJECT HAS BEEN INITIATED TO FURTHER REVIEW OUR SILICONE PROCESS. 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.

    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.

    Description of Event or Problem · 0

    NEW SYRINGE WITH VISCOUS SUBSTANCE INSIDE. NEW SYRINGE WITH VISCOUS SUBSTANCE INSIDE AT THE SYRINGE CONE (WHERE THE BLACK PLUNGER RESTS). SUBSTANCE SEEN IN SMALLER QUANTITIES ON ANOTHER SAMPLE FROM THE SAME BATCH. BEFORE USE CIRCUMSTANCES OF OCCURRENCE / DESCRIPTION OF FACTS : BEFORE PREPARING AN INTRAVENOUS TREATMENT, A PAEDIATRIC IDE A NOTICED A DEPOSIT AT THE BOTTOM OF THE 50ML LUER LOCK SYRINGE. SHE NOTES THAT THIS DEPOSIT IS PRESENT IN ALL THE IDENTICAL SYRINGES IN THE DEPARTMENT'S MATERIAL STOCK. AFTER HANDLING, WE FIND THAT THIS DEPOSIT IS AN ODORIFEROUS, "GREASY/VISCOUS" PRODUCT. CONSERVATION MEASURES AND ACTIONS TAKEN CONTACT WITH CHU'S MATERIALOVIGILANCE DEPARTMENT, PARAMEDICS NOTIFIED. CLINICAL CONSEQUENCES OBSERVED : UNUSED SYRINGE.

    Description of Event or Problem · 0

    NEW SYRINGE WITH VISCOUS SUBSTANCE INSIDE: NEW SYRINGE WITH VISCOUS SUBSTANCE INSIDE AT THE SYRINGE CONE (WHERE THE BLACK PLUNGER RESTS). SUBSTANCE SEEN IN SMALLER QUANTITIES ON ANOTHER SAMPLE FROM THE SAME BATCH. BEFORE USE: CIRCUMSTANCES OF OCCURRENCE / DESCRIPTION OF FACTS : BEFORE PREPARING AN INTRAVENOUS TREATMENT, A PAEDIATRIC IDE A NOTICED A DEPOSIT AT THE BOTTOM OF THE 50ML LUER. LOCK SYRINGE. SHE NOTES THAT THIS DEPOSIT IS PRESENT IN ALL THE IDENTICAL SYRINGES IN THE DEPARTMENT'S MATERIAL STOCK. AFTER HANDLING, WE FIND THAT THIS DEPOSIT IS AN ODORIFEROUS, "GREASY/VISCOUS" PRODUCT. CONSERVATION MEASURES AND ACTIONS TAKEN: CONTACT WITH CHU'S MATERIAL VIGILANCE DEPARTMENT, PARAMEDICS NOTIFIED. CLINICAL CONSEQUENCES OBSERVED : UNUSED SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471103 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON SEE MANUFACTURER NARRATIVE 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown