BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIXING CONNECTOR WITH SPRAY TIP

    MDR report key: 9686790 · Received February 7, 2020

    Report

    Report Number
    MW5092873
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    November 14, 2019
    Report Date
    January 30, 2020
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON NOVEMBER 14TH DR. (B)(6) WAS USING ZIMMER BIOMET GPS. DR. (B)(6) WAS INJECTING THE GPS PRODUCT NUMBER 800-0252 LOT # 20700. DR. (B)(6) LATER FOUND OUT THAT HE HAD LEFT THE SCREW ON TIP OF PRODUCT 800-0252 IN THE PATIENT. PATIENT WAS BROUGHT BACK FOR SURGERY ON 12-10 AND THE TIP WAS REMOVED. DR. (B)(6) CHECKED THE TIP THAT WAS LEFT IN THE PATIENT WITH ANOTHER 800-0252 AND THE TIP SCREWED ON PERFECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147725 MIXING CONNECTOR WITH SPRAY TIP SYRINGE, PISTON FMF MICROMEDICS, INC. 800-0252 207002

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention