BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ MICROBORE TRI-EXTENSION

    MDR report key: 16359736 · Received February 11, 2023

    Report

    Report Number
    9610847-2023-00025
    Event Type
    Malfunction
    Date Received
    February 11, 2023
    Date of Event
    January 21, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851584
    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 FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 01-FEB-2023. H6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 TRI-EXTENSION SET RETURNED WITH 4 Q-SYTE SAMPLES, ONE WAS A STANDALONE, AND 1 PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FLOW ISSUES - FLUID BLOCKAGE WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT 1 OF THE Q-SYTES SAMPLES DID NOT HAVE THE PROPER SLIT OPENING. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED TO THE MANUFACTURING PROCESS. DURING THE MANUFACTURING PROCESS THE SEPTUMS OF THE Q-SYTES HAVE A SLIT CUT INTO THEM VIA A BLADE. IF THE BLADE IS DULL, BROKEN, OR MISSING IN THE MANUFACTURING MACHINERY THAN THE SLIT WILL NOT BE PROPERLY CUT INTO THE SEPTUM RESULTING IN THE REPORTED DEFECT. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MET OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WERE FLOW ISSUES AND BLOCKAGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD Q-SYTE SMALL BORE TRI EXT. 2 LUMEN BLOCKED. IN ICU BD Q-SYTE TRI EXT. IS GETTING USED, AND SEPTUM IS CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WERE FLOW ISSUES AND BLOCKAGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD Q-SYTE SMALL BORE TRI EXT. 2 LUMEN BLOCKED. IN ICU BD Q-SYTE TRI EXT. IS GETTING USED, AND SEPTUM IS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607354 BD Q-SYTE¿ MICROBORE TRI-EXTENSION INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1151553 00382903851584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown