BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 10170347 · Received June 18, 2020

    Report

    Report Number
    3003152976-2020-00259
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 26, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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: 6/12/2020. H.6. INVESTIGATION: SIXTY SAMPLES OF LOT 2001253 WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. THE SAMPLES WERE VISUALLY INSPECTED AND NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK AND THE STOPPER WAS PROPERLY ASSEMBLED TO THE PLUNGER. LEAKAGE TESTING WAS PERFORMED AND NO LEAKS WERE IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2001253, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2001253 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS WERE IDENTIFIED, THE STOPPERS WERE PROPERLY ASSEMBLED, AND NO LEAKAGES OCCURRED. 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. BASED ON OUR INVESTIGATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN FILLING A 50 ML SYRINGE (BD LUER-LOCK REF 300865, LOT: 2001253, VALIDITY: 2024/12) WITH DOXORUBICIN, IT STARTED TO LEAK THROUGH THE PLUNGER, EVEN PASSING TO THE BOTTOM OF THE SYRINGE. IT WAS NECESSARY TO REPEAT THE PREPARATION 4 TIMES, BECAUSE WHENEVER IT WAS NECESSARY TO TOUCH THE PLUNGER TO RECTIFY THE VOLUME, DOXORUBICIN CAME OUT THROUGH THE BOTTOM OF THE SYRINGE. IN THE SYRINGE THAT WAS SENT WITH THE PREPARATION, WE DID NOT MOVE THE PLUNGER AFTER FILLING WITH DOXORUBICIN, WITH TWO VERY SMALL BUBBLES REMAINING. WE CONTACTED THE NURSES AT THE ONCOLOGY DAY HOSPITAL TO REPORT WHAT HAD HAPPENED AND SO THAT WHEN INJECTING THE SOLUTION INTO THE PATIENT WITHOUT MAJOR INCIDENTS".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN FILLING A 50 ML SYRINGE (BD LUER-LOCK REF 300865, LOT: 2001253, VALIDITY: 2024/12) WITH DOXORUBICIN, IT STARTED TO LEAK THROUGH THE PLUNGER, EVEN PASSING TO THE BOTTOM OF THE SYRINGE. IT WAS NECESSARY TO REPEAT THE PREPARATION 4 TIMES, BECAUSE WHENEVER IT WAS NECESSARY TO TOUCH THE PLUNGER TO RECTIFY THE VOLUME, DOXORUBICIN CAME OUT THROUGH THE BOTTOM OF THE SYRINGE. IN THE SYRINGE THAT WAS SENT WITH THE PREPARATION, WE DID NOT MOVE THE PLUNGER AFTER FILLING WITH DOXORUBICIN, WITH TWO VERY SMALL BUBBLES REMAINING. WE CONTACTED THE NURSES AT THE (B)(6) HOSPITAL TO REPORT WHAT HAD HAPPENED AND SO THAT WHEN INJECTING THE SOLUTION INTO THE PATIENT WITHOUT MAJOR INCIDENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635645 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2001253

    Patients

    Seq Age Sex Outcome Treatment
    1 Other