BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD INSULIN SYRINGE WITH 30 G X 8 MM BD ULTRA-FINE II¿ NEEDLE

    MDR report key: 8546262 · Received April 24, 2019

    Report

    Report Number
    1920898-2019-00383
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (10) 1CC, 8MM, 30G SYRINGES IN A SEALED POLY BAG FROM LOT # 7240673. CUSTOMER STATES THAT THEY NOTICED A CAP DROP OFF ON ONE OF THE ITEMS. THE RETURNED POLY BAG WAS EXAMINED AND EXHIBITED ONE SYRINGE WITH THE SHIELD OFF IN THE BAG. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240673. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200713528] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSE IS LIKELY DURING THE AUTO PACKAGING OPERATION THAT THE SHIELD COULD CATCH ON THE OUTSIDE OF THE CARTON AND WHEN THE PRODUCT TAMP STATION PRESSES THE AIR OUT OF THE BAGS THE SHIELD COULD BE REMOVED EXPOSING THE CANNULA. THIS WOULD LIKELY PROCEED THROUGH THE SYSTEM UNDETECTED UNLESS IT WAS DETECTED DURING HOURLY VISUAL INSPECTIONS FOR MISSING COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A STERILITY ISSUE WITH A 1 ML BD INSULIN SYRINGE WITH 30 G X 8 MM BD ULTRA-FINE II¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING STOCKING OF ITEM ONTO SHELF, PHARMACIST NOTICED A CAP DROP OFF ON ONE OF THE ITEMS, IMMEDIATELY REPORTED TO US.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A STERILITY ISSUE WITH A 1 ML BD INSULIN SYRINGE WITH 30 G X 8 MM BD ULTRA-FINE II¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING STOCKING OF ITEM ONTO SHELF, PHARMACIST NOTICED A CAP DROP OFF ON ONE OF THE ITEMS, IMMEDIATELY REPORTED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337522 1 ML BD INSULIN SYRINGE WITH 30 G X 8 MM BD ULTRA-FINE II¿ NEEDLE INSULN SYRINGE FMI BD MEDICAL - DIABETES CARE 7240673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other