BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE

    MDR report key: 8104260 · Received November 26, 2018

    Report

    Report Number
    1920898-2018-00905
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    October 15, 2018
    Report Date
    December 4, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282807
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED (10) 3/10CC, 12.7MM, 30G SYRINGES IN A SEALED POLY BAG FROM LOT # 7072979. CUSTOMER STATES THAT THE RUBBER STOPPER IS MELTED. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGE TO THE STOPPER WAS OBSERVED ON ANY OF THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7072979 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200682026] NOTED FOR DRY BARRELS. THERE WERE TWO (2) NOTIFICATIONS [200690248, 200690374] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RUBBER STOPPER ON THE BD ULTRA-FINE NEEDLE INSULIN SYRINGE WAS "MELTED".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 THE RUBBER STOPPER ON THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WAS "MELTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940530 BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7072979 00382903282807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other