BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 16244591 · Received January 25, 2023

    Report

    Report Number
    1920898-2023-00018
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    January 7, 2023
    Report Date
    January 27, 2023
    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

    H6: INVESTIGATION SUMMARY; NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. CUSTOMER RETURNED AN IMAGE OF THE 30GX8MM BD SYRINGE. THE CUSTOMER REPORTED VENDOR LOT & EXPIRY DATE NOT CLEAR. THE IMAGES WERE EXAMINED, AND IT WAS OBSERVED THAT THE LOT NUMBER, MANUFACTURING DATE AND EXPIRATION DATE IS BLURRY AND UNCLEAR ON THE SHELF CARTON. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2052365. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE IMAGES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF PACKING PRINTING DEFECT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOT ON THE BD ULTRA-FINE¿ II INSULIN SYRINGE WAS NOT CLEAR ON THE LABEL. THIS OCCURRED WITH 200 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VENDOR LOT & EXPIRY DATE NOT CLEAR".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOT ON THE BD ULTRA-FINE¿ II INSULIN SYRINGE WAS NOT CLEAR ON THE LABEL. THIS OCCURRED WITH 200 SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VENDOR LOT & EXPIRY DATE NOT CLEAR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793133 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown