BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE

    MDR report key: 10892237 · Received November 24, 2020

    Report

    Report Number
    2243072-2020-01921
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 18, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: LOT#0041571 DHR AND MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. 7PCS RETENTION SAMPLES WERE CHECKED THE LEAKAGE THROUGH CLOG TEST, THERE IS NO LEAKAGE DETECTED, THE WATER WAS FLOWED THROUGH THE CANNULA TIP WHICH IS MEET REQUIREMENT. NO RETURNED SAMPLES OR ACTUAL DEFECT SAMPLES FOR INVESTIGATION, SO WE CAN¿T PERFORM IN-DEPTH INVESTIGATION. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    LEAKAGE OF INJECTION NEEDLE WAS FOUND DURING USE.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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)(4).

    Description of Event or Problem · 1

    LEAKAGE OF INJECTION NEEDLE WAS FOUND DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354736 PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON 0041571

    Patients

    Seq Age Sex Outcome Treatment
    1