BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 17546613 · Received August 14, 2023

    Report

    Report Number
    1920898-2023-00556
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 27, 2023
    Report Date
    October 19, 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

    H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF (19) 0.3ML 29GA 12.7MM SYRINGES FROM THE LOT# 2234021, 14 IN A SEALED POLYBAG, 5 IN AN OPEN POLYBAG. THIS REPORT IS ABOUT HUB SEPARATION. WHEN THE CAP WAS REMOVED, THE NEEDLE HUB WAS TAKEN OFF. THE RETURNED SAMPLES WERE VISUALLY EXAMINED AND OBSERVED NO ISSUES, NO ISSUES WERE OBSERVED WITH NEEDLE HUB SEPARATES. NO ISSUES OF ANY KIND WAS OBSERVED ON THE RETURNED SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2234021. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. 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 HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE WHEN THE CAP WAS REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT HUB SEPARATION. WHEN THE CAP WAS REMOVED, THE NEEDLE HUB WAS TAKEN OFF."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE WHEN THE CAP WAS REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT HUB SEPARATION. WHEN THE CAP WAS REMOVED, THE NEEDLE HUB WAS TAKEN OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50276 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2234021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP.