BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL CONVENIENCE TRAY EUROPE

    MDR report key: 11675501 · Received April 15, 2021

    Report

    Report Number
    3003152976-2021-00201
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 18, 2021
    Report Date
    May 24, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 4/21/2021 H.6. INVESTIGATION: A TOTAL OF SIX SAMPLES, ONE WHICH APPEARS TO HAVE BEEN USED, WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED IN THE USED SAMPLE. IT WAS NOTED THE BARREL WAS DAMAGED WHICH LIKELY LEAD TO THE LEAKAGE THAT OCCURRED. ALL RETURNED PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED IN THE FIVE UNUSED SAMPLES THAT COULD HAVE CAUSED A LEAK, NO DEFECTS WERE IDENTIFIED IN ANY OF THE PLUNGER RODS, AND ALL STOPPERS WERE VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOT 2011059, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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, INCLUDING LEAKAGE TESTING TO VERIFY THE STOPPER SEAL. RESULTS WERE REVIEWED FOR THE LOT 2011059 AND NO ISSUES WERE IDENTIFIED. THE RETURNED SAMPLES UNDERWENT THESE SAME TESTS AND PRODUCT WAS FOUND TO MEET REQUIRED SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A LEAKAGE RELATED TO THE UNUSED SAMPLES, HOWEVER, GIVEN THE DAMAGE OBSERVED IN THE USED SAMPLE, IT IS LIKELY THE DAMAGE OCCURRED DURING MANUFACTURING AND RESULTED IN THE REPORTED LEAK. A DEFINITIVE CAUSE OF THE DAMAGE CANNOT BE IDENTIFIED AT THIS TIME. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 SYRINGES 20ML LL CONVENIENCE TRAY EUROPE LEAKED LIQUID PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: "WE HAVE LATELY HAD PROBLEMS WHEN WE HAVE TO FILL 20 ML SYRINGES (CONVENIENCE PACK) WITH ANTIBIOTICS. WHAT HAPPENS IS THAT LIQUID IS FORCED PAST THE BLACK RUBBER AND UP INTO THE PISTON AS IF IT DOES NOT CLOSE TIGHTLY. WE USE A BAXA PUMP TO HELP WITH FILLING. ON A HUNDRED PRE-FILLED SYRINGES, THERE IS ON AVERAGE ONE THAT FAILS AND MUST BE REPLACED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 SYRINGES 20ML LL CONVENIENCE TRAY EUROPE LEAKED LIQUID PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WE HAVE LATELY HAD PROBLEMS WHEN WE HAVE TO FILL 20 ML SYRINGES (CONVENIENCE PACK) WITH ANTIBIOTICS. WHAT HAPPENS IS THAT LIQUID IS FORCED PAST THE BLACK RUBBER AND UP INTO THE PISTON AS IF IT DOES NOT CLOSE TIGHTLY. WE USE A BAXA PUMP TO HELP WITH FILLING. ON A HUNDRED PRE-FILLED SYRINGES, THERE IS ON AVERAGE ONE THAT FAILS AND MUST BE REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567077 SYRINGE 20ML LL CONVENIENCE TRAY EUROPE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2011059

    Patients

    Seq Age Sex Outcome Treatment
    1