BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8283634 · Received January 28, 2019

    Report

    Report Number
    2243072-2019-00128
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 15, 2019
    Report Date
    March 1, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. UNABLE TO PERFORM DHR CHECK FOR DIFFICULT/UNABLE TO OPERATE, NEEDLE BENT AND PLUNGER ROD LOOSE DUE TO UNKNOWN LOT NUMBER. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE PLUNGER OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS UNSTABLE, AND ITS NEEDLES WERE NOT STRAIGHT, RESULTED IN RECEIVING INACCURATE DOSE OF INSULIN. D.1. MEDICAL DEVICE BRAND NAME: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE D.2. MEDICAL DEVICE TYPE: FMF D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL - DIABETES CARE D.4. COMMON DEVICE NAME: INSULIN SYRINGE WITH NEEDLE D.4. MEDICAL DEVICE CATALOG: 328466 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BD MEDICAL - DIABETES CARE G.5. PMA/510(K)#: K024112

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS UNSTABLE, AND ITS NEEDLES WERE NOT STRAIGHT, RESULTED IN RECEIVING INACCURATE DOSE OF INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER OF BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS UNSTABLE, AND ITS NEEDLES WERE NOT STRAIGHT, RESULTED IN RECEIVING INACCURATE DOSE OF INSULIN.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS UNKNOWN. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PLUNGERS OF UNSPECIFIED BD¿ INSULIN SYRINGES WAS UNSTABLE, AND ITS NEEDLES WERE NOT STRAIGHT, RESULTED IN RECEIVING INACCURATE DOSE OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73447 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other