BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MDS-21NRFIT

    MDR report key: 18678409 · Received February 9, 2024

    Report

    Report Number
    1213809-2024-00072
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 10, 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

    PR 9632232 FOLLOW UP REPORT FOR CORRECTION. THE DATE RECEIVED BY MANUFACTURER WAS INCORRECT IN THE INITIAL MDR, DATE SHOULD BE 29-JAN-2024.

    Additional Manufacturer Narrative · 0

    PR 9632232¿ 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE RETURNED FOR THE BD SYRINGE NRFIT¿ SLIP, PRODUCT CODE# 400051, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. 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. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. H3 OTHER TEXT : SEE NARRATIVE BELOW

    Additional Manufacturer Narrative · 0

    PR# (B)(4) FOLLOW UP REPORT FOR CORRECTIONS. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE NRFIT¿ SLIP WAS USED IN A STUDY AND THAT THE PARTICIPANT REPORTED URINARY RETENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ABOVE MENTIONED CUSTOMER IS PARTICIPATING IN THE MDS-21NRFIT001 STUDY. BD SYRINGE NRFIT (CATALOG NUMBER/TYPE/SIZE) 400051/SYRINGE NRFIT SLIP/5ML 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 THE ADVERSE EVENT ¿ URINARY RETENTION¿ WAS REPORTED ON (B)(6) 2024 AND WAS RESOLVED THE SAME DAY. SEVERITY: MILD SITE ASSESSED THE EVENT AT FIRST AS NOT RELATED TO EVERY THING, BUT AFTER BEING QUERIED FOR MORE DETAILS, HAS NOW CHANGE THE ASSESSMENT TO ¿POSSIBLE¿ RELATED TO PROCEDURE. ¿ 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 SUBJECT WAS TREATED WITH URINARY CATHETER. SITE CONFIRMED IN A QUERY RESPONSE THAT URINARY RETENTION OCCURRED AFTER 4, 5 HOURS OF THE PROCEDURE AND THERE IS NO HISTORY OF URINARY RETENTION IN THE SUBJECT. THERE WERE NO COMPLICATIONS OCCURRED DURING THE PROCEDURE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379614 MDS-21NRFIT PISTON SYRINGE QEH BECTON DICKINSON MEDICAL SYSTEMS MDS-21NRFIT 00382904000516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R