BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2 ML WITH 25G X 1

    MDR report key: 13542036 · Received February 16, 2022

    Report

    Report Number
    2243072-2022-00218
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 3, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿BLACK SPOT, FOREIGN PARTICLES, BLISTER LEAKAGE¿ WITH LOT NUMBER 1203233 REGARDING ITEM # 301866, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE INVESTIGATION AND SIMULATION WAS CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR BLACK SPOT, FOREIGN PARTICLES, BLISTER LEAKAGE AND THE REPORTED ISSUE WAS NOT FOUND. AS NO SAMPLES OR PHOTOGRAPHS ARE AVAILABLE THE INVESTIGATION TEAM COULD NOT CONFIRM THE REPORTED DEFECT OF BLACK SPOT, FOREIGN PARTICLES, BLISTER LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED BD DISCARDIT II 2 ML WITH 25G X 1 HAD FOREIGN MATERIAL AND OPEN PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK SPOT, FOREIGN , PARTICLES, BLISTER LEAKAGE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD DISCARDIT II 2 ML WITH 25G X 1 HAD FOREIGN MATERIAL AND OPEN PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK SPOT, FOREIGN , PARTICLES, BLISTER LEAKAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537856 BD DISCARDIT II 2 ML WITH 25G X 1 PISTON SYRINGE FMF BECTON DICKINSON 1203233

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown