BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ QUINCKE SPINAL NEEDLE

    MDR report key: 15182842 · Received August 8, 2022

    Report

    Report Number
    3003152976-2022-00356
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    June 28, 2022
    Report Date
    August 30, 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES THAT DISPLAYS THE REPORTED CONDITION WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD¿ QUINCKE SPINAL NEEDLE THE SPINAL NEEDLE IS NOT ABLE TO TIE PROPERLY WITH THE SYRINGE, SO THERE IS EVIDENCE OF DRIPPING OF THE DRUG WHEN INFUSING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: PATIENT TO WHOM INTRATHECAL CHEMOTHERAPY IS BEING ADMINISTERED AND THE SPINAL NEEDLE IS NOT ABLE TO TIE PROPERLY WITH THE SYRINGE, SO THERE IS EVIDENCE OF DRIPPING OF THE DRUG WHEN INFUSING IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD¿ QUINCKE SPINAL NEEDLE THE SPINAL NEEDLE IS NOT ABLE TO TIE PROPERLY WITH THE SYRINGE, SO THERE IS EVIDENCE OF DRIPPING OF THE DRUG WHEN INFUSING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: PATIENT TO WHOM INTRATHECAL CHEMOTHERAPY IS BEING ADMINISTERED AND THE SPINAL NEEDLE IS NOT ABLE TO TIE PROPERLY WITH THE SYRINGE, SO THERE IS EVIDENCE OF DRIPPING OF THE DRUG WHEN INFUSING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380012 BD¿ QUINCKE SPINAL NEEDLE ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2111005

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male