BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® QUINCKE SPINAL NEEDLES 27GA 3.50 IN

    MDR report key: 14489052 · Received May 24, 2022

    Report

    Report Number
    3003152976-2022-00229
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    April 22, 2022
    Report Date
    July 6, 2022
    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

    PATIENT¿S BIRTHDAY WAS NOT PROVIDED, (B)(6) 1964 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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE PHOTO WAS PROVIDED WHICH DISPLAYS A SPINAL NEEDLE INSIDE IT IS ORIGINAL UNITARY SEALED PACKAGE. THERE IS NO DAMAGE OR OTHER DEFECTS OBSERVED IN THE PHOTO THAT COULD HAVE LEAD TO THE LEAK REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2111005, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR CRACKS 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 2111005 VERIFIED PRODUCT MET ALL REQUIRED LIMITS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® QUINCKE SPINAL NEEDLES 27GA 3.50 IN LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE DESCRIPTION IT IS INFORMED "THREAD LEAKAGE WHEN APPLYING", COULD YOU PLEASE CLARIFY IF: (A) WAS THERE LEAKAGE AT THE THREAD PART? R: YES, THERE WAS A LEAKAGE; R: THERE IS ONLY THIS REPORT. ONLY 1 REPORTED. AS SOON AS THE INCIDENT WAS NOTICED, THE USAGE OF THE DEVICE IS SUSPENDED AND CHANGED TO ANOTHER OPTION. CUSTOMER CLEARLY CONFIRMS THERE WAS A LEAKAGE THROUGH THE LUER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® QUINCKE SPINAL NEEDLES 27GA 3.50 IN LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE DESCRIPTION IT IS INFORMED "THREAD LEAKAGE WHEN APPLYING", COULD YOU PLEASE CLARIFY IF: (A) WAS THERE LEAKAGE AT THE THREAD PART? R: YES, THERE WAS A LEAKAGE; R: THERE IS ONLY THIS REPORT. ONLY 1 REPORTED. AS SOON AS THE INCIDENT WAS NOTICED, THE USAGE OF THE DEVICE IS SUSPENDED AND CHANGED TO ANOTHER OPTION. CUSTOMER CLEARLY CONFIRMS THERE WAS A LEAKAGE THROUGH THE LUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220479 BD® QUINCKE SPINAL NEEDLES 27GA 3.50 IN ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2111005

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female