BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ULTRA-FINE INSULIN SYRINGE

    MDR report key: 8242030 · Received January 11, 2019

    Report

    Report Number
    1920898-2018-01003
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 26, 2018
    Report Date
    February 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282890
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED (3) LOOSE 1CC, 8MM SYRINGES. CUSTOMER STATES THAT WHEN DRAWING AND DURING THE INJECTION, THE PLUNGER BREAKS. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED A BROKEN PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8092810. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. PROBABLE ROOT CAUSES: FOR BROKEN PLUNGERS: DRY BARRELS (INSUFFICIENT SILICONE) FROM THE PREP DIAL THAT RESULT FROM A SILICONE GUN NOT FIRING. INSUFFICIENT SILICONE LEADS TO DIFFICULTY EXERCISING THE PLUNGER, AND CAN THEREBY RESULT IN BROKEN PLUNGERS. PLUNGER SCREW JAMS THAT WOULD DAMAGE PLUNGERS, I.E., THEY BREAK PLUNGERS. BOWED PLUNGERS THAT DO NOT GET SEATED, AND GET BROKEN OFF AT THE DELRIN WHEEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO PLUNGERS OF BD¿ ULTRA-FINE INSULIN SYRINGE WERE BROKEN WHEN DRAWING INSULIN FROM VIAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT TWO PLUNGERS OF BD¿ ULTRA-FINE INSULIN SYRINGE WERE BROKEN WHEN DRAWING INSULIN FROM VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33880 BD¿ ULTRA-FINE INSULIN SYRINGE INSULIN SYRINGE/NEEDLE FMF BD MEDICAL - DIABETES CARE 8092810 00382903282890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other