BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 17759299 · Received September 15, 2023

    Report

    Report Number
    1920898-2023-00628
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 21, 2023
    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

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEW-LIKE FOREIGN MATTER CAME OUT OF THE BD ULTRA-FINE¿ II INSULIN SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THIS REPORT IS ABOUT FM. A DEW-LIKE FOREIGN MATTER CAME OUT OF THE SYRINGE. NOTHING HAD BEEN DRAWN INTO THE INSULIN YET. ONE OF THE PRODUCTS WAS DEFECTIVE, BUT DUE TO CONCERNS, ALL PRODUCTS IN THE SAME BOX WERE RETURNED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEW-LIKE FOREIGN MATTER CAME OUT OF THE BD ULTRA-FINE¿ II INSULIN SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT FM. A DEW-LIKE FOREIGN MATTER CAME OUT OF THE SYRINGE. NOTHING HAD BEEN DRAWN INTO THE INSULIN YET. ONE OF THE PRODUCTS WAS DEFECTIVE, BUT DUE TO CONCERNS, ALL PRODUCTS IN THE SAME BOX WERE RETURNED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328555 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown