BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINENEEDLE

    MDR report key: 10775323 · Received November 2, 2020

    Report

    Report Number
    1920898-2020-01507
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 8, 2020
    Report Date
    November 13, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282906
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DHR COULD NOT BE PERFORMED DUE TO THE UNKNOWN LOT#.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR BD INSULIN SYRINGES WITH BD ULTRA-FINE¿NEEDLES EXPERIENCED THE CANNULA BREAKING OFF OR PULLING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER REPORTED WHEN DRAWING THE MEDICATION FROM THE VIAL, THE NEEDLE SEPARATES AND GOES INTO THE VIAL. STATED THIS HAPPENED WITH 4 SYRINGES. LOT # 0060224, CAT # 328290, DATE OF EVENT: 10/08/20.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR BD INSULIN SYRINGES WITH BD ULTRA-FINE¿NEEDLES EXPERIENCED THE CANNULA BREAKING OFF OR PULLING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER REPORTED WHEN DRAWING THE MEDICATION FROM THE VIAL, THE NEEDLE SEPARATES AND GOES INTO THE VIAL. STATED THIS HAPPENED WITH 4 SYRINGES. LOT # 0060224. CAT # 328290. DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241045 BD INSULIN SYRINGES WITH BD ULTRA-FINENEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328290 UNKNOWN 00382903282906

    Patients

    Seq Age Sex Outcome Treatment
    1