BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD PMCF-Q-SYTE-EXTENSION-SET

    MDR report key: 11667410 · Received April 14, 2021

    Report

    Report Number
    2243072-2021-01118
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 7, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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), NJ HAS BEEN LISTED IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ PMCF-Q-SYTE-EXTENSION-SET TUBING CAUSED THE CLINICIAN TO EXPERIENCE AN INFECTION ON 4 OCCASIONS, HAD FLOW ISSUES ON 5 OCCASIONS, AND EXPOSED THE CLINICIAN TO BLOOD ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED VIA SURVEY RESPONSE THE CLINICIAN EXPERIENCED LOCALISED INFECTION (4), FLOW RATE SLOW (2), FLOW RATE OCCLUDED (3), CLINICIAN EXPOSURE TO BLOOD (2), A BLOCKED CAP (1). ADDITIONAL INFORMATION RELATED TO CLINICIAN EXPOSURE TO BLOOD STATES: "AN ACCIDENTAL LEAK FROM THE TUBE". ADDITIONAL INFORMATION RELATED TO LOCALISED INFECTION STATES: "THE PATIENT WAS IN A POOR CONDITION, FEVER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565917 UNSPECIFIED BD PMCF-Q-SYTE-EXTENSION-SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other