BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD UNIVIA¿ WHITACRE SPINAL NEEDLE

    MDR report key: 13194994 · Received January 7, 2022

    Report

    Report Number
    3003152976-2021-00890
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    November 26, 2021
    Report Date
    February 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    BSP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PHOTOS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, TWO USED SPINAL NEEDLES ARE OBSERVED. UNABLE TO CONFIRM THE FAILURE BASED ON THE PHOTOS RECEIVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2102006, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, NO ANOMALIES OR ISSUES WERE OBSERVED. FUNCTIONAL TEST WAS PERFORMED, SAMPLE WAS CONNECTED TO A SYRINGE, DURING THE TEST THE FLUID PASSED FROM THE SYRINGE THROUGH THE SPINAL NEEDLE AND NO LEAKAGE WAS NOTED AT THE LUER CONNECTION. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNIVIA¿ WHITACRE SPINAL NEEDLE BROKE AND LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING SPINAL ANESTHESIA PROCEDURE IN A PATIENT WITH A PENCIL POINT WHITACRE BD 27 SPINAL NEEDLE, ANESTHETIC LEAKAGE WAS OBSERVED AT THE JUNCTION OF THE NEEDLE AND MANDREL AND THE NEEDLE BROKE. A NEW PUNCTURE HAD TO BE PERFORMED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNIVIA¿ WHITACRE SPINAL NEEDLE BROKE AND LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING SPINAL ANESTHESIA PROCEDURE IN A PATIENT WITH A PENCIL POINT WHITACRE BD 27 SPINAL NEEDLE, ANESTHETIC LEAKAGE WAS OBSERVED AT THE JUNCTION OF THE NEEDLE AND MANDREL AND THE NEEDLE BROKE. A NEW PUNCTURE HAD TO BE PERFORMED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNIVIA¿ WHITACRE SPINAL NEEDLE BROKE AND LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "DURING SPINAL ANESTHESIA PROCEDURE IN A PATIENT WITH A PENCIL POINT WHITACRE BD 27 SPINAL NEEDLE, ANESTHETIC LEAKAGE WAS OBSERVED AT THE JUNCTION OF THE NEEDLE AND MANDREL AND THE NEEDLE BROKE. A NEW PUNCTURE HAD TO BE PERFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477535 BD UNIVIA¿ WHITACRE SPINAL NEEDLE ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2102006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown