BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12185991 · Received July 16, 2021

    Report

    Report Number
    9610847-2021-00337
    Event Type
    Injury
    Date Received
    July 16, 2021
    Date of Event
    June 17, 2021
    Report Date
    August 23, 2021
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/5/2021. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0171911. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, THE SAMPLE SUBMITTED BY THE FACILITY HAS BEEN REVIEWED BY OUR TEAM OF QUALITY ENGINEERS. DURING VISUAL OBSERVATION OF THE DEVICE THEY NOTED THAT THE SEPTUM HAD BEEN IMPACTED. THE ISSUE HAS BEEN CONFIRMED. CLOSER INSPECTION OF THE DEVICE ALSO SHOWED THAT THE ADHESIVE COATING USED TO SECURE THE SEPTUM TO THE BODY OF THE QSYTE WAS ADEQUATELY APPLIED AND THE DEVICE WAS ASSEMBLED IN ACCORDANCE WITH OUR CURRENT OPERATING PROCEDURE. WITH THE EXCEPTION OF MISSING ADHESIVE, AN IMPACTED SEPTUM CAN BE CAUSED BY NUMEROUS POTENTIAL SOURCES, INCLUDING USE, THAT DO NOT LEAVE DAMAGE, OR MARKS THAT ARE INDICATIVE OF A SPECIFIC CAUSE. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS DEFORMED, AND CLOGGED. THE PRODUCT DEFECTS RESULTED IN THE PATIENT EXPERIENCING LIFE-THREATENINGLY LOW BLOOD PRESSURE. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS APPLIED. THE FINAL OUTCOME FOR THE PATIENT HAS NOT BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NORADRENALINE SYRINGE + SLANG HAD TO BE REPLACED. THE PATIENT DROPS IN BLOOD PRESSURE AFTER THIS. DESPITE MEASURES (INCREASE NORADRENALINE DOSE) NOTHING HAPPENED. THE PATIENT HAS TIME TO GET A BLOOD PRESSURE OF 40/20 BEFORE WE NOTICE THAT THE RUBBER MEMBRANE TO THE GATE ON THE CVK HAS COME LOOSE AND "WENT IN" INTO THE GATE AND THEREFORE THE CVK BLOCKS AND NO NORADRENALINE CAN ENTER THE PATIENT.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS DEFORMED, AND CLOGGED. THE PRODUCT DEFECTS RESULTED IN THE PATIENT EXPERIENCING LIFE-THREATENINGLY LOW BLOOD PRESSURE. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS APPLIED. THE FINAL OUTCOME FOR THE PATIENT HAS NOT BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NORADRENALINE SYRINGE + SLANG HAD TO BE REPLACED. THE PATIENT DROPS IN BLOOD PRESSURE AFTER THIS. DESPITE MEASURES (INCREASE NORADRENALINE DOSE) NOTHING HAPPENED. THE PATIENT HAS TIME TO GET A BLOOD PRESSURE OF 40/20 BEFORE WE NOTICE THAT THE RUBBER MEMBRANE TO THE GATE ON THE CVK HAS COME LOOSE AND "WENT IN" INTO THE GATE AND THEREFORE THE CVK BLOCKS AND NO NORADRENALINE CAN ENTER THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081774 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA 385100 0171911 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening