BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGES

    MDR report key: 15533387 · Received October 3, 2022

    Report

    Report Number
    1920898-2022-00673
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 12, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THREE PHOTOS OF 0.3ML BD INSULIN SYRINGES FROM LOT# 0286306 WERE PROVIDED. THE CUSTOMER REPORTED THAT THERE IS LIQUID IN THE SYRINGES. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT A TRANSPARENT MATERIAL WAS PRESENT INSIDE THE SYRINGE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0020548. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED (FM). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ INSULIN SYRINGES FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY INSULIN SYRINGES SOMETIMES HAVE A CLEAR LIQUID EQUIVALENT TO A DROP OF ONE MILLIMETER IN DIAMETER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ INSULIN SYRINGES FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY INSULIN SYRINGES SOMETIMES HAVE A CLEAR LIQUID EQUIVALENT TO A DROP OF ONE MILLIMETER IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768475 BD ULTRA-FINE¿ INSULIN SYRINGES PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0020548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown