BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE?¿ II INSULIN SYRINGE

    MDR report key: 15991973 · Received December 15, 2022

    Report

    Report Number
    1920898-2022-00880
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 24, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    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

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED AN IMAGE OF A SINGLE 0.3ML SYRINGE. THE SYRINGE HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1123322. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE PHOTO RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ II INSULIN SYRINGE WHEN REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "A PET CAREGIVER GETS IN TOUCH TO REPORT THAT ONE OF THE 30UI BD ULTRA-FINE SYRINGES HAD THE FOLLOWING QUALITY DEVIATION: WHEN REMOVING THE ORANGE PROTECTIVE COVER, THE NEEDLE DETACHED ITSELF FROM THE SYRINGE BODY AND REMAINED ATTACHED TO THE PROTECTIVE COVER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ II INSULIN SYRINGE WHEN REMOVING THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "A PET CAREGIVER GETS IN TOUCH TO REPORT THAT ONE OF THE 30UI BD ULTRA-FINE SYRINGES HAD THE FOLLOWING QUALITY DEVIATION: WHEN REMOVING THE ORANGE PROTECTIVE COVER, THE NEEDLE DETACHED ITSELF FROM THE SYRINGE BODY AND REMAINED ATTACHED TO THE PROTECTIVE COVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734812 BD ULTRA-FINE?¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1123322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown