BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE

    MDR report key: 15180098 · Received August 5, 2022

    Report

    Report Number
    1920898-2022-00517
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A SINGLE 0.3ML SYRINGE. THE SYRINGE¿S NEEDLE SHIELD IS DAMAGED, WITH PORTIONS THAT APPEAR TO HAVE PULLED, COMPRESSED, OR OTHERWISE WARPED THE MATERIAL. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SHIELD DAMAGE. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE EXPERIENCED A BREACH IN STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE: THE USER FOUND A DEFORMED SHIELD OF SYRINGE BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE EXPERIENCED A BREACH IN STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE: THE USER FOUND A DEFORMED SHIELD OF SYRINGE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469115 BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown