BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MDS-21NRFIT

    MDR report key: 18705138 · Received February 14, 2024

    Report

    Report Number
    1213809-2024-00081
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 22, 2024
    Report Date
    March 15, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    QEH
    UDI-DI
    00382904000516
    PMA / PMN Number
    K192538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT #2 FOR CORRECTIONS. THIS COMPLAINT WAS FOUND TO BE A DUPLICATE AFTER THE MDR WAS SUBMITTED, PLEASE REFER TO (B)(4). THE MANUFACTURING PLANT WAS INCORRECT IN THE INITIAL MDR. THE MANUFACTURING PLANT SHOULD BE BECTON DICKINSON - FRANKLIN LAKES, NJ / 07417. EVENT DETAILS HAVE BEEN UPDATED: ADVERSE EVENT WITH NO MALFUNCTION, DEVICE UNRELATED. ADVERSE EVENT RELATED TO PROCEDURE ONLY. MEDICAL DEVICE BRAND NAME, MEDICAL DEVICE CATALOG #, AND MEDICAL DEVICE LOT # HAVE BEEN UPDATED TO REFLECT THE NRFIT ANESTHESIA STUDY. NO PRODUCT IDENTIFIED AS CAUSE FOR THE ADVERSE EVENT. EVENT RELATED TO PROCEDURE ONLY. PMA/510K HAS BEEN UPDATED TO NA.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADVERSE EVENT WITH NO MALFUNCTION, DEVICE UNRELATED. ADVERSE EVENT RELATED TO PROCEDURE ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE NRFIT¿ SLIP WAS INVOLVED IN A STUDY AND PATIENT "COLLAPSED DURING THE PUNCTURE ATTEMPT AND THEN WANTED A GENERAL ANESTHESIA." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ABOVE MENTIONED CUSTOMER IS PARTICIPATING IN THE MDS-21NRFIT001 STUDY. THE PATIENT PERFORMED A SPINAL ANESTHESIA WITH THE FOLLOWING NRFIT DEVICES ON (B)(6) 2024. HOWEVER, THE ANESTHETIC MEDICATION WAS NOT SUCCESSFULLY INJECTED THROUGH THE BD SYRINGE AS PATIENT COLLAPSED DURING THE PUNCTURE ATTEMPT AND THEN WANTED A GENERAL ANESTHESIA. BD SYRINGE NRFIT LOT NUMBER: 83149, ANCILLARY DEVICE USED (CATALOGUE NUMBER/TYPE/SIZE): 400066/BD BLUNT FILTER NRFIT NEEDLE/18G X 1 1/2(1.2 MM X 40 MM). BD BLUNT FILL OR BLUNT FILTER NRFIT NEEDLE LOT NUMBER: 3045501. BD SYRINGE NRFIT (CATALOG NUMBER/TYPE/SIZE): 400051/SYRINGE NRFIT SLIP/5ML. BD SPINAL NRFIT NEEDLE SET LOT NUMBER : 2109032. AN ADVERSE EVENT "HYPOTENSION WITH BRADYCARDIA" WAS REPORTED ON (B)(6) 2024 AND RESOLVED ON THE SAME DAY. THE ADVERSE EVENT WAS TREATED WITH AKRINOR 100MG. AND PATIENT WAS LAID DOWN. DEVICE WAS REMOVED AND SUBJECT WAS GIVEN GENERAL ANESTHESIA. RELATIONSHIP TO SPINAL NEEDLE: NOT RELATED. RELATIONSHIP TO SYRINGE: NOT RELATED. RELATIONSHIP TO INTRODUCER: NOT RELATED. RELATIONSHIP TO ANCILLARY DEVICES: NOT RELATED. RELATIONSHIP TO PROCEDURE: POSSIBLE. THE ADVERSE EVENT OCCURRED AFTER USING THE DEVICE. THE EVENT IS POSSIBLY RELATED TO PROCEDURE. THIS COMPLAINT HAS BEEN REPORTED BECAUSE IT HAS A POSSIBLE RELATIONSHIP WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424440 MDS-21NRFIT PISTON SYRINGE QEH BECTON DICKINSON MEDICAL SYSTEMS MDS-21NRFIT 00382904000516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other