BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE NON STERILE 50ML LL

    MDR report key: 10705115 · Received October 20, 2020

    Report

    Report Number
    3003152976-2020-00455
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 25, 2020
    Report Date
    October 21, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. BASED ON THE PHOTO, THE STOPPER IS ASSEMBLED PROPERLY ONTO THE PLUNGER AND THERE IS NO VISIBLE DAMAGE OR DEFECTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED LEAK. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1904352, 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 TIGHTNESS VERIFICATION OF THE STOPPER. PRODUCT THAT FAILS THIS TESTING IS AUTOMATICALLY REJECTED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE NON STERILE 50ML LL LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO YOU BECAUSE THIS MORNING WE RECEIVED A REPORT FROM ONE OF OUR CUSTOMERS ABOUT A DEFECTIVE ASN-50 SYRINGE. IN PARTICULAR THE DEFECT IS THE LEAKAGE OF LIQUIDS FROM THE PISTON OF THE SYRINGE, AS SHOWN IN THE PICTURES.

    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 NON STERILE 50 ML LL LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO YOU BECAUSE THIS MORNING WE RECEIVED A REPORT FROM ONE OF OUR CUSTOMERS ABOUT A DEFECTIVE ASN-50 SYRINGE. IN PARTICULAR THE DEFECT IS THE LEAKAGE OF LIQUIDS FROM THE PISTON OF THE SYRINGE, AS SHOWN IN THE PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173790 SYRINGE NON STERILE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1904352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other