BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 15452219 · Received September 19, 2022

    Report

    Report Number
    1920898-2022-00625
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 23, 2022
    Report Date
    November 1, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (7) 3/10CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 1256984. CUSTOMER STATES THAT DARK DIRT WAS FOUND ONTO THE BARREL. ALL RETURNED SYRINGES WERE EXAMINED AND 3 OUT OF 7 SAMPLES EXHIBITED INK SMEARED ON THE SURFACE OF THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1256984. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT-CAUSE: DISPATCH 133669: DIRTY SPINDLE CUP; DOCTOR BLADE WAS NOT SEATED ALL THE WAY DOWN THE SHAFT CAUSING INK TO FILL THE SPINDLE CUPS AND COAT THE PADS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIRT-LIKE FOREIGN MATTER WAS FOUND IN THE BARRELS OF 2 BD ULTRA-FINE¿ II INSULIN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE USER REPORTED THAT THE DARK DIRT WAS FOUND ONTO THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIRT-LIKE FOREIGN MATTER WAS FOUND IN THE BARRELS OF 2 BD ULTRA-FINE¿ II INSULIN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE USER REPORTED THAT THE DARK DIRT WAS FOUND ONTO THE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698659 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1256984

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown