BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE)

    MDR report key: 18027153 · Received October 29, 2023

    Report

    Report Number
    2243072-2023-01965
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4 DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE) THE CUSTOMER EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CLINICIAN EXPERIENCED: -YES, I DID ENCOUNTER OTHER COMPLICATIONS DIRECTLY RELATED TO THE LAST BD Q-STYLE EXTENSION SET I USED ON THIS PATIENT -DIFFICULTY IN TRANSIT IF THE INFUSION BEGINS AND IT IS INCREASINGLY MALLEABLE AND BENDS MORE EASILY. IT WAS REPORTED THAT CLINICIAN AND/OR ANY PATIENTS HAVE ENCOUNTERED FLOW ISSUES WHEN USING THE BD Q-STYLE EXTENSION SET.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED EXTERNAL REF # (B)(4). ES47. MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT CLINICIAN AND/OR ANY PATIENTS HAVE ENCOUNTERED FLOW ISSUES WHEN USING THE BD Q-STYLE EXTENSION SET. VERBATIM: CLINICIAN EXPERIENCED: YES, I DID ENCOUNTER OTHER COMPLICATIONS DIRECTLY RELATED TO THE LAST BD Q-STYLE EXTENSION SET I USED ON THIS PATIENT DIFFICULTY IN TRANSIT IF THE INFUSION BEGINS AND IT IS INCREASINGLY MALLEABLE AND BENDS MORE EASILY. PLEASE SEE ATTACHED EXCEL SHEET FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138448 UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE) INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown