BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 11900540 · Received May 28, 2021

    Report

    Report Number
    1213809-2021-00380
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 3, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND THREE SEALED 3ML SYRINGES (P/N 309657) CONFIRMED TO BE FROM BATCH #1041510 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. ALL THREE SYRINGES WERE MISSING MORE THAN FIFTY PERCENT OF THEIR PRINTED SURFACE. SOME PRINT WAS PRESENT FROM THE ZERO GRAD LINE TO JUST ABOVE THE 2ML GRAD LINE ON TWO OF THE SYRINGES WITH MUCH OF THE PRINT PRESENT BEING MISSING OR ILLEGIBLE. ONE SYRINGE WAS ONLY PRINTED FROM THE ZERO GRAD LINE TO JUST ABOVE THE 1.5ML GRAD LINE. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT WAS LIKELY THAT AN INK FLOW ISSUE PREVENTED THE PROPER AMOUNT OF INK FROM BEING TRANSFERRED TO THE BARREL. THE DEFECT WAS DETECTED PRIOR TO THE BATCH LEAVING THE FACILITY AND PRODUCT REQUALIFIED PER APPLICABLE ACCEPTABLE QUALITY LIMIT. IT IS POSSIBLE THAT NOT ALL DEFECTS WERE CONTAINED AS PART OF THE REQUALIFICATION ACTIVITIES AND A LIMITED NUMBER WITH THIS CONDITION WERE NOT DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " ITEM #309657 3ML LL SYRINGE IS MISSING MARKINGS ON THE SYRINGE."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ITEM #309657 3ML LL SYRINGE IS MISSING MARKINGS ON THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796699 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 1041510 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1