BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SPINAL NEEDLE 27GA 3.50 IN

    MDR report key: 15245857 · Received August 17, 2022

    Report

    Report Number
    3003152976-2022-00375
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    April 19, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NON-CONFORMANCES WERE REPORTED DURING PRODUCTION OF BATCH 2201009. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A FAILURE RELATED TO THE DEVICE OR ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING OPERATION WHILE USING THE BD SPINAL NEEDLE 27GA 3.50 IN THE PATIENT SUFFERED FROM HYPOTENSION. HYPOTENSION WAS SOLVED DURING OPERATION. THE AE WAS ASSESSED BY INVESTIGATOR AS NOT SERIOUS, RELATED TO SPINAL PROCEDURE, NOT RELATED TO SPINAL NEEDLE, INTRODUCER, STYLET AND SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A 29 YEARS OLD FEMALE PARTICIPANT IN THE MDS-20EPSPEU001 STUDY WITH NUMBER 0506, HAD SPINAL NEEDLE PROCEDURE ON (B)(6) 2022 AT L3-4. THE PATIENT SUFFERED FROM HYPOTENSION ON (B)(6) 2022, MILD IN INTENSITY, RECOVERED ON (B)(6) 2022. PATIENT WAS TREATED WITH PHENYLEPHRINE DOSES AND FLUID WERE GIVEN. HYPOTENSION WAS SOLVED DURING OPERATION. THE AE WAS ASSESSED BY INVESTIGATOR AS NOT SERIOUS, RELATED TO SPINAL PROCEDURE, NOT RELATED TO SPINAL NEEDLE, INTRODUCER, STYLET AND SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369694 BD SPINAL NEEDLE 27GA 3.50 IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2201009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention