BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 14429624 · Received May 18, 2022

    Report

    Report Number
    1920898-2022-00342
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 3, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED AN IMAGE OF SEVERAL SHELF CARTONS. ALL INFORMATIONAL PRINT SEEMS TO BE PRESENT ON THE SHELF CARTONS, INCLUDING MANUFACTURING INFORMATION, BARCODE, ETC. THE SHELF CARTONS APPEAR UNIFORM IN PRINT. NO PRINTING ERRORS ARE IMMEDIATELY VISIBLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1102610. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGE RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF MISSING SHELF CARTON INFORMATION. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS MISSING INFORMATION ON LABEL OF BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRINTING LABEL LACK OF INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS MISSING INFORMATION ON LABEL OF BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRINTING LABEL LACK OF INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604965 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1102610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown