BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7059415 · Received November 27, 2017

    Report

    Report Number
    1920898-2017-00339
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 2, 2017
    Report Date
    January 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - CUSTOMER RETURNED (1) LOOSE 1CC, 8MM SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED ADHESIVE RUNOFF ONTO THE HUB. THE RETURNED SYRINGE WAS TESTED AND WAS NOT ABLE TO DRAW PROPERLY. CONCLUSION - PROBABLE ROOT CAUSE DETERMINED TO BE MISALIGNMENT DURING APPLICATION OF ADHESIVE ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE RUNOVER ONTO THE HUB OR POSSIBLE THE CANNULA MAY OCCUR. ADDITIONALLY, ADHESIVE MAY BE INACCURATELY APPLIED TO THE RUBBERIZED PULL WHEEL ON THE LINE, WHICH CAN ADDITIONALLY TRANSFER ADHESIVE TO THE CANNULA DURING ROUTINE USE. CAPA (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS ADHESIVE RUNOVER.

    Additional Manufacturer Narrative · 1

    NO LOT # PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: 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 SEVERAL BD INSULIN SYRINGE(S) WITH THE BD ULTRA-FINE¿ NEEDLE(S) LEAKED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841382 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other