BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 14311712 · Received May 6, 2022

    Report

    Report Number
    1920898-2022-00318
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 15, 2022
    Report Date
    June 9, 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, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 16-MAY-2022. H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE 0.3ML SYRINGE. THE BARREL FLANGE WAS BROKEN ON ONE SIDE. IT WAS NOTED THAT THE PLUNGER ROD WAS FULLY INTACT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1123341 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE BARREL FLANGE BEING BROKEN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION. B.5. DESCRIBE EVENT OR PROBLEM - ADDITIONAL EVENT TYPE INCLUDES BROKEN FLANGE. D.4. MEDICAL DEVICE LOT #: UPDATED FROM UNKNOWN TO 1123341. D.4. MEDICAL DEVICE EXPIRATION DATE: DATE ADDED - 31-MAY-2026. H.4. DEVICE MANUFACTURE DATE: DATE ADDED - 03-MAY-2021. H6: EVENT PROBLEM AND EVALUATION CODES: NEW A CODE (A0401) ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER ROD WAS BROKEN ON THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE PLUNGER ROD WAS BROKEN IN ONE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLANGE WAS BROKEN ON THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE PLUNGER ROD WAS BROKEN IN ONE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLANGE WAS BROKEN ON THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE PLUNGER ROD WAS BROKEN IN ONE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098802 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1123341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown