BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ TRI-EXTENSION SET

    MDR report key: 17024579 · Received May 30, 2023

    Report

    Report Number
    9616066-2023-01033
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 6, 2023
    Report Date
    June 16, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851584
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SILICON SEPTUM ENTRANCE OF THE Q-SYTE WAS BLOCKED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. INVESTIGATION OF THE ACTUAL SAMPLE WOULD BE NECESSARY TO CONFIRM THE REPORTED FAILURE MODE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 385158, LOT NUMBERS 2033442, 2060348 AND 2122453. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NONCONFORMANCE(S), CAPAS OR ABNORMAL CONDITIONS NOTED AT THE TIME OF PRODUCTION. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF Q-SYTES USED IN THE MANUFACTURING OF THIS BATCH AND NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCHES. BASED ON THE INVESTIGATION, BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2033442 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025 H.4. DEVICE MANUFACTURE DATE: 21-FEB-2022 D.4. MEDICAL DEVICE LOT #: 2060348 D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025 H.4. DEVICE MANUFACTURE DATE: 29-APR-2022 D.4. MEDICAL DEVICE LOT #: 2122453 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025 H.4. DEVICE MANUFACTURE DATE: 17-MAY-2022 H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ TRI-EXTENSION SET SEPTUM WAS BLOCKED. THIS OCCURRED 20 TIMES EACH IN LOTS 2033442, 2060348, AND 2122453. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING A DISCUSSION WITH THE CUSTOMER, THE HEALTHCARE WORKER FOUND THAT THE SILICON SEPTUM ENTRANCE (HUB) OF Q-SYTE TRI EXTENSION SMALL BORE WAS BLOCKED. HAVE TO CREATE ANOTHER INDENT BY HEALTHCARE WORKER DUE TO THIS BLOCKED SEPTUM"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ TRI-EXTENSION SET SEPTUM WAS BLOCKED. THIS OCCURRED 20 TIMES EACH IN LOTS 2033442, 2060348, AND 2122453. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING A DISCUSSION WITH THE CUSTOMER, THE HEALTHCARE WORKER FOUND THAT THE SILICON SEPTUM ENTRANCE (HUB) OF Q-SYTE TRI EXTENSION SMALL BORE WAS BLOCKED. HAVE TO CREATE ANOTHER INDENT BY HEALTHCARE WORKER DUE TO THIS BLOCKED SEPTUM"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728136 BD Q-SYTE¿ TRI-EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H10 00382903851584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown