BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLLECTOR

    MDR report key: 9070076 · Received September 16, 2019

    Report

    Report Number
    2243072-2019-02024
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO UPDATED INFORMATION THIS EVENT IS NO LONGER ATTRIBUTED TO A MALFUNCTION OF A BD DEVICE AND IS THEREFORE NOT A REPORTABLE EVENT. 'THE COMPLAINT IS ABOUT THE DESIGN OF THE SHARPS BIN FOR CHEM. THERE IS NO DEVICE FAILURE IN THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD SHARPS COLLECTOR DID NOT HAVE THE GUIDES AT THE OPENING TO PREVENT THE SHARPS FROM ESCAPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 8L CHEMOTHERAPY SHARPS CONTAINER DOES NOT HAVE GUIDES AT THE OPENING TO PREVENT THE SHARPS FROM ESCAPING IF THE CONTAINER IS ACCIDENTALLY KNOCKED OVER (COMPARED WITH THE REGULAR SHARPS CONTAINERS).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD SHARPS COLLECTOR DID NOT HAVE THE GUIDES AT THE OPENING TO PREVENT THE SHARPS FROM ESCAPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 8L CHEMOTHERAPY SHARPS CONTAINER DOES NOT HAVE GUIDES AT THE OPENING TO PREVENT THE SHARPS FROM ESCAPING IF THE CONTAINER IS ACCIDENTALLY KNOCKED OVER (COMPARED WITH THE REGULAR SHARPS CONTAINERS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868040 BD SHARPS COLLECTOR SHARPS DISPOSAL FMI BECTON DICKINSON 19141005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other