BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE 3/10ML 8MM 31G

    MDR report key: 16317100 · Received February 7, 2023

    Report

    Report Number
    1920898-2023-00044
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 15, 2023
    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

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2192372. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II INSULIN SYRINGE 3/10ML 8MM 31G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HE HAS NOTICED THAT THERE IS A SMALL DROP OF CLEAR LIQUID SILICON. IF BY CHANCE THERE WAS MORE LIQUID THAN NORMAL ON THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II INSULIN SYRINGE 3/10ML 8MM 31G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HE HAS NOTICED THAT THERE IS A SMALL DROP OF CLEAR LIQUID SILICON. IF BY CHANCE THERE WAS MORE LIQUID THAN NORMAL ON THIS LOT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229419 BD ULTRA-FINE¿ II INSULIN SYRINGE 3/10ML 8MM 31G PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2192372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown