BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® QUINCKE SPINAL NEEDLE 27G

    MDR report key: 16212624 · Received January 19, 2023

    Report

    Report Number
    3003152976-2023-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 15, 2022
    Report Date
    February 14, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    BSP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2111012, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON OR NEAR THE LUER CONNECTION. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE NEEDLE TO A SYRINGE. LIQUID WAS ABLE TO PASS FROM THE SYRINGE THROUGH THE NEEDLE AND NO LEAKAGE WAS OBSERVED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. TESTING RESULTS FOR LOT 2111012 VERIFIED PRODUCT MET ALL REQUIRED LIMITS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    PATIENT¿S BIRTHDAY WAS NOT PROVIDED, 01JAN WAS USED BASED ON AGE OF PATIENT. 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 · 0

    IT WAS REPORTED WHILE USING BD® QUINCKE SPINAL NEEDLE 27G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE SPINAL NEEDLE HAS A DEFECT IN SYRINGE CONNECTION, PRESENTING A LEAKAGE DURING MEDICATION ADMINISTRATION. IT WAS NOT POSSIBLE TO INJECT THE ANESTHESIA. THERE WAS NO DAMAGE TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® QUINCKE SPINAL NEEDLE 27G LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE SPINAL NEEDLE HAS A DEFECT IN SYRINGE CONNECTION, PRESENTING A LEAKAGE DURING MEDICATION ADMINISTRATION. IT WAS NOT POSSIBLE TO INJECT THE ANESTHESIA. THERE WAS NO DAMAGE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395035 BD® QUINCKE SPINAL NEEDLE 27G ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2111012

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male