BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 12285187 · Received August 5, 2021

    Report

    Report Number
    1920898-2021-00860
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED SEVERAL IMAGES OF SHELF CARTONS FOR 0.5ML, 30 GAUGE, 8MM SYRINGES FROM LOT 0153026. ONE SHELF CARTON FEATURES A GASH ON ONE SIDE. OTHER CARTONS ARE CRUMPLED ON MULTIPLE FACES. LASTLY, ONE CARTON FEATURES A MISPRINT OF THE LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE. WHILE THIS INFORMATION IS PRINTED CORRECTLY, A SECOND PRINTING OF THIS INFORMATION OCCURS TO THE LEFT, COMING OUT AS COMPRESSED AND OVERLAPPING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0153026 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABEL PRINT ON THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE PACKAGING WAS ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DUPLICATE LOT = 1 SP"

    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 THE LABEL PRINT ON THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE PACKAGING WAS ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DUPLICATE LOT = 1 SP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176740 BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0153026

    Patients

    Seq Age Sex Outcome Treatment
    1