BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 18027128 · Received October 29, 2023

    Report

    Report Number
    1920898-2023-00743
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 16, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBER INCLUDES 3121508. H.3. 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 · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD CANAAN MACHINE OPERATOR MARY WELLS GAVE 3ML PRODUCT (X2, 30965780) TO HR ADMINISTRATIVE COORDINATOR ((B)(6)) WHO THEN NOTED TO COMPLAINT DEPT THAT THE SYRINGES WERE DEFECTIVE FOR ROLLED SCALE. CUSTOMER COMPLAINT DEPARTMENT CURRENTLY IN POSSESSION OF SAMPLES WHICH WERE MANUFACTURED AT THE MDS SITE IN HOLDREGE NEBRASKA. NURSE OR DOCTOR AT MEDICAL FACILITY (ALBANY MEDICAL CENTER) GAVE BD EMPLOYEE (MARY WELLS) SYRINGES WITH ROLLED SCALE, NOTING THAT THE DEFECT MADE THE SYRINGES DIFFICULT TO USE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME." NOTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130895 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2353713 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown