BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITACRE SET 27GA 3-1/2IN

    MDR report key: 11697897 · Received April 20, 2021

    Report

    Report Number
    3003152976-2021-00210
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 21, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THOUGH VISUAL INSPECTION, THE NEEDLE IS OBSERVED TO HAVE BROKEN, VERIFYING THE REPORTED FAILURE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 2001019 AND 2001007, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS EVALUATED USING MAGNIFICATION, NO DEFECTS WERE OBSERVED ON THE NEEDLE THAT MAY CAUSE A BREAK AND THE STYLET COULD BE REMOVED WITHOUT ISSUE. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS THE ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THE NEEDLE IS FREE FROM DAMAGE OR DEFECTS. ALL INSPECTIONS FOR LOTS 2001019 AND 2001007 WERE COMPLETED ACCORDING TO PROCEDURE, NO ANNOTATIONS WERE NOTED RELATED TO THE REPORTED INCIDENT. BASED ON THE AVAILABLE INFORMATION 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 WHITACRE SET 27GA 3-1/2IN NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS ADMITTED TO THE WARD FOR EMERGENCY HEMORRHOID SURGERY WITH BLEEDING, OPTING FOR REGIONAL ANESTHESIA, UNDER SEDATION AT THE REQUEST OF THE PATIENT, IN LATERAL DECUBITUS AND UNDER MONITORING, THE PROCEDURE IS STARTED UNDER ASEPTIC TECHNIQUE, 2% LIDOCAINE LOCAL ANESTHETIC INFILTRATION, L3-L4 SPACE IS PUNCTURED FACED WITH WHICH THE PATIENT HAS AVOIDANCE MOVEMENTS, IN RELATION TO THIS A METALLIC CLICK IS HEARD, THE TROCAR IS REMOVED IMMEDIATELY, OBSERVING THAT IT IS INCOMPLETE, AN EVALUATION IS REQUESTED BY A NEUROSURGEON WHO WITH RADIOLOGICAL ASSISTANCE IDENTIFIES THE MISSING SEGMENT IN THE SOFT TISSUES. IT WAS DECIDED TO REMOVE IT SURGICALLY AFTER INFORMING THE FAMILY AND TELEPHONE AUTHORIZATION, GIVEN THAT THE PATIENT WAS UNDER REQUESTED SEDATION. UNDER GENERAL ANESTHESIA, THE MISSING SEGMENT WAS REMOVED. TO THEN CONTINUE WITH THE EMERGENCY SURGERY THAT THE PATIENT REQUIRED. 03/25/2021: ADD INFO RECEIVED. DESPITE OF THE CUSTOMER DOES NOT HAVE THE EXACT BATCH SINCE THE PACKAGING WAS ELIMINATED WITHOUT THE OPPORTUNITY TO RESCUE IT, TODAY THEY REQUESTED THAT WE CHANGE THE 300 UNITS THEY HAVE IN THEIR WAREHOUSES FOR ANOTHER BATCH, THE MAJORITY IS FROM BATCH 2001019 AND A LITTLE BIT OF LOT 2001007. 03/29/2021: SAMPLES IS WITH SALES REP.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITACRE SET 27GA 3-1/2IN NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS ADMITTED TO THE WARD FOR EMERGENCY HEMORRHOID SURGERY WITH BLEEDING, OPTING FOR REGIONAL ANESTHESIA, UNDER SEDATION AT THE REQUEST OF THE PATIENT, IN LATERAL DECUBITUS AND UNDER MONITORING, THE PROCEDURE IS STARTED UNDER ASEPTIC TECHNIQUE, 2% LIDOCAINE LOCAL ANESTHETIC INFILTRATION, L3-L4 SPACE IS PUNCTURED FACED WITH WHICH THE PATIENT HAS AVOIDANCE MOVEMENTS, IN RELATION TO THIS A METALLIC CLICK IS HEARD, THE TROCAR IS REMOVED IMMEDIATELY, OBSERVING THAT IT IS INCOMPLETE, AN EVALUATION IS REQUESTED BY A NEUROSURGEON WHO WITH RADIOLOGICAL ASSISTANCE IDENTIFIES THE MISSING SEGMENT IN THE SOFT TISSUES. IT WAS DECIDED TO REMOVE IT SURGICALLY AFTER INFORMING THE FAMILY AND TELEPHONE AUTHORIZATION, GIVEN THAT THE PATIENT WAS UNDER REQUESTED SEDATION. UNDER GENERAL ANESTHESIA, THE MISSING SEGMENT WAS REMOVED. TO THEN CONTINUE WITH THE EMERGENCY SURGERY THAT THE PATIENT REQUIRED. 03/25/2021: ADD INFO RECEIVED. DESPITE OF THE CUSTOMER DOES NOT HAVE THE EXACT BATCH SINCE THE PACKAGING WAS ELIMINATED WITHOUT THE OPPORTUNITY TO RESCUE IT, TODAY THEY REQUESTED THAT WE CHANGE THE 300 UNITS THEY HAVE IN THEIR WAREHOUSES FOR ANOTHER BATCH, THE MAJORITY IS FROM BATCH 2001019 AND A LITTLE BIT OF LOT 2001007. 03/29/2021: SAMPLES IS WITH SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590419 WHITACRE SET 27GA 3-1/2IN NEEDLE FMI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention