BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 12351739 · Received August 20, 2021

    Report

    Report Number
    9610847-2021-00389
    Event Type
    Death
    Date Received
    August 20, 2021
    Date of Event
    July 21, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 2021-08-17. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED Q-SYTE DEVICE AND THREE PHOTOGRAPHS. THROUGH THE INITIAL VISUAL INSPECTION OF THE RETURNED DEVICE, DAMAGE WAS NOT OBSERVED. THE Q-SYTE UNIT WAS THEN TESTED FOR LEAKAGE IN BOTH THE ACTUATED AND UNACTUATED POSITIONS. LEAKAGE THROUGH THE VENT HOLE WAS OBSERVED ONLY IN THE ACTUATED POSITION. THIS IS INDICATIVE OF DAMAGE TO THE COLUMN WALL AND/OR BOTTOM DISK. THE SEPTUM WAS THEN REMOVED FROM THE TOP AND BOTTOM BODY OF THE Q-SYTE FOR FURTHER MICROSCOPIC INSPECTION. DAMAGE WAS NOT OBSERVED TO THE TOP DISK HOWEVER SLIGHT DAMAGE WAS OBSERVED TO THE SLIT OF THE BOTTOM DISK. THE BOTTOM DISK SLIT WAS THEN GRADED AND FOUND TO PASS SPECIFICATION. A TEAR WAS ALSO FOUND ON THE COLUMN WALL WHICH WOULD ALLOW LEAKAGE TO OCCUR THROUGH THE VENT HOLE. ALTHOUGH THE FAILURE STATED IN THE REPORTED ISSUE WAS CONFIRMED WITH THE UNIT PROVIDED FOR INVESTIGATION, BD COULD NOT ESTABLISH A DEFINITE ROOT CAUSE. DAMAGE TO THE COLUMN CAN OCCUR DURING MANUFACTURING DUE TO MISALIGNMENT OR DAMAGED/BURRED PROBES. DURING USE, EXCESSIVE ACTUATIONS OR EXTRANEOUS FORCE ON THE SEPTUM MAY ALSO RESULT IN TEARING OF THE SEPTUM WALL. AS THE DEVICE HAS BEEN OPENED AND USED, IT CANNOT BE CONCLUSIVELY LINKED TO EITHER MANUFACTURING OR USE AS THE DEFECT WOULD HAVE THE SAME APPEARANCE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.2. DEATH? YES. B.2. DATE OF DEATH: (B)(6) 2021. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD Q-SYTE LUER ACCESS SPLIT SEPTUM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT LEAKAGE FROM Q-SYTE." ACCORDING TO THE CUSTOMER'S REPORT, THE INFUSION FLUID (VASOPRESSOR) LEAKED FROM THE SIDE OF Q-SYTE (WHICH AFFECTED PATIENT'S CONDITIONS). BD WAS NOTIFIED THAT AFTER THE INCIDENT REPORTED, THE PATIENT HAD A MORTALITY OUTCOME. H.1. TYPE OF REPORTABLE EVENT: DEATH. H.6. IMDRF ANNEX E GRID: E2401 - INSUFFICIENT INFORMATION. H.6. IMDRF ANNEX F GRID: F02 - DEATH. H.6. IMDRF ANNEX A GRID: A24 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM (2993).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE LUER ACCESS SPLIT SEPTUM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT LEAKAGE FROM Q-SYTE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE LUER ACCESS SPLIT SEPTUM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT LEAKAGE FROM Q-SYTE." ACCORDING TO THE CUSTOMER'S REPORT, THE INFUSION FLUID (VASOPRESSOR) LEAKED FROM THE SIDE OF Q-SYTE (WHICH AFFECTED PATIENT'S CONDITIONS). BD WAS NOTIFIED THAT AFTER THE INCIDENT REPORTED, THE PATIENT HAD A MORTALITY OUTCOME.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT BD Q-SYTE LUER ACCESS SPLIT SEPTUM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT LEAKAGE FROM Q-SYTE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245662 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 1021707 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown