BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 17389980 · Received July 25, 2023

    Report

    Report Number
    1911916-2023-00511
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 31, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MDR IS A DUPLICATE OF 1911916-2023-00421 THIS SUPPLEMENTAL IS TO CANCEL MDR.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2088560 D.4. MEDICAL DEVICE EXPIRATION DATE: NA H.4. DEVICE MANUFACTURE DATE: 29-MAR-2022 D.4. MEDICAL DEVICE LOT #: 1274029 D.4. MEDICAL DEVICE EXPIRATION DATE: NA H.4. DEVICE MANUFACTURE DATE: 01-OCT-2021 H.3. 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 · 0

    IT WAS REPORTED THAT AT LEAST ONE BD PRECISIONGLIDE¿ NEEDLE EACH FROM LOTS 2088560 AND 1274029 HAD EXCESSIVE EPOXY ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS NEEDLE SYRINGE PRESENTS EXCESSIVE BONDING ADHESIVE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD PRECISIONGLIDE¿ NEEDLE EACH FROM LOTS 2088560 AND 1274029 HAD EXCESSIVE EPOXY ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS NEEDLE SYRINGE PRESENTS EXCESSIVE BONDING ADHESIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336320 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown