BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SPINAL NEEDLE QUINCKE TYPE POINT

    MDR report key: 17337994 · Received July 17, 2023

    Report

    Report Number
    3003152976-2023-00288
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 22, 2023
    Report Date
    August 11, 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 PHOTOS OR 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

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD SPINAL NEEDLE QUINCKE TYPE POINT MEDICATION LEAKED AT LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MATCHING THE SYRINGE WITH THE MEDICATION SPILLS THE ANESTHETIC

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD SPINAL NEEDLE QUINCKE TYPE POINT MEDICATION LEAKED AT LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MATCHING THE SYRINGE WITH THE MEDICATION SPILLS THE ANESTHETIC

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664736 BD SPINAL NEEDLE QUINCKE TYPE POINT ANESTHETIC CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2111012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown