BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE 27GA 3.50 IN

    MDR report key: 10617011 · Received October 1, 2020

    Report

    Report Number
    3002682307-2020-00294
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 9, 2020
    Report Date
    January 11, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. THREE RETAINED SAMPLES OF THE LOT 1910022 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUAL INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE PRODUCT. DRIP TESTING WAS PERFORMED, THE SAMPLES WERE CONNECTED TO THE APPROPRIATE LUER FITTING, ALL CONNECTIONS WERE SECURE, AND NO LEAKAGE FROM THE HUB OCCURRED . THE NEEDLE WAS THEN CONNECTED TO A SYRINGE AND ADDITIONAL LEAKAGE TESTING WAS CONDUCTED, IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGE WAS IDENTIFIED. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY OF THE DEVICE, INCLUDING VERIFICATION THAT ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1910022, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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 THAT DRUG LEAKED FROM THE SIDE OF THE SPINAL NEEDLE 27GA 3.50 IN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "THE DRUG IS DISPENSED FROM THE SIDES BECAUSE THE LUER LOCK DOES NOT CLOSE PROPERLY, WHICH IS WHY THE DOSE IS LOST, REQUIRES POSITIONING OF THE NEEDLE, THE PUNCTURE MAY BE LOST AND A NEW ONE MAY BE REQUIRED, THE CALCULATION OF THE ADMINISTERED DOSE IS ALSO LOST, INCREASES THE RISK OF FAILED SPINAL ANESTHESIA, THERE IS A RISK OF OVER OR UNDERDOSING.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DRUG LEAKED FROM THE SIDE OF THE SPINAL NEEDLE 27 GA 3.50 IN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE DRUG IS DISPENSED FROM THE SIDES BECAUSE THE LUER LOCK DOES NOT CLOSE PROPERLY, WHICH IS WHY THE DOSE IS LOST, REQUIRES POSITIONING OF THE NEEDLE, THE PUNCTURE MAY BE LOST AND A NEW ONE MAY BE REQUIRED, THE CALCULATION OF THE ADMINISTERED DOSE IS ALSO LOST, INCREASES THE RISK OF FAILED SPINAL ANESTHESIA, THERE IS A RISK OF OVER OR UNDERDOSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075676 SPINAL NEEDLE 27GA 3.50 IN ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 1910022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other