BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE

    MDR report key: 9106710 · Received September 23, 2019

    Report

    Report Number
    2618282-2019-00252
    Event Type
    Injury
    Date Received
    September 23, 2019
    Date of Event
    September 5, 2019
    Report Date
    October 1, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    UDI-DI
    30382904050796
    PMA / PMN Number
    K091758
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDE PHOTOS OR SAMPLES FOR CATALOG 405079 LOT 9011708 TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. AFTER REVIEWING THE DEVICE HISTORY RECORDS, MATERIALS, PROCESSES, AND PROCEDURES, NO NON-CONFORMANCES OR CHANGES WERE IDENTIFIED AS IT RELATES TO THE NEEDLE MANUFACTURING PROCESS. SINCE NO SAMPLE WAS RECEIVED FOR EVALUATION, DHRS, MATERIALS, PROCESS AND PROCEDURES WERE ASSESSED. 1. MATERIAL - COMPLAINT LOT USED DURING THE ASSEMBLY CANNULA MATER 031940 LOT 8219955, 8219950 AND 8065905. INCOMING INSPECTION RECORDS WERE VERIFIED FOR THESE CANNULAS LOTS AND INSPECTIONS WERE EXECUTED AS EXPECTED DURING THE RECEIVING OF THE LOT. THE DRAWING AND SPECIFICATION FOR THE CANNULA WERE VERIFIED AND NO CHANGES IN THE CANNULA MATERIAL WERE PERFORMED. 2. MACHIN/EQUIPMENT - DEVICE HISTORY RECORD REVIEW FOR THE LOT NUMBERS IMPACTED WAS PERFORMED AND NO NON-CONFORMANCES IMPACTING POTENTIAL SPINAL NEEDLE CANNULA BREAKAGE WERE OBSERVED. ALL THE INSPECTIONS WERE PERFORMED AS ESTABLISHED PER PROCEDURES WITH SATISFACTORY RESULTS. THUS, PREVENTIVE MAINTENANCE AND INSTRUMENT CALIBRATION WERE IN COMPLIANCE. 3. PROCESS/METHODS/PROCEDURE - NO CHANGES REGARDING MANUFACTURING OR INSPECTION PROCESS / METHODS/ PROCEDURES OF THE AFFECTED COMPONENTS IN THE LAST YEARS. CONCLUSION: BD JUNCOS WAS NOT ABLE TO CONFIRM THAT THE CUSTOMER'S INDICATED FAILURE MODE IS ASSOCIATED WITH THE MANUFACTURING PROCESSES. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE HAS BEEN FOUND WITH THE NEEDLE BREAKING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PATIENT WHO PRESENTS SPINAL NEEDLE FRACTURE AT THE TIME OF SPINAL ANESTHESIA. REQUIRED: NEUROSURGEON EVALUATION, POSITION WITH FLUOROSCOPE IS VERIFIED, INCISION IS MADE, THE FRAGMENT IS REMOVED AND SKIN IS SUTURED. THE HOSPITAL STAY IS NOT PROLONGED OR THE PATIENT'S INITIAL MANAGEMENT PLAN IS CHANGED. HE LEAVES THE INSTITUTION ON THE SAME DAY AND INFORMS THE PATIENT AND FAMILY OF THE EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE HAS BEEN FOUND WITH THE NEEDLE BREAKING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PATIENT WHO PRESENTS SPINAL NEEDLE FRACTURE AT THE TIME OF SPINAL ANESTHESIA. REQUIRED: NEUROSURGEON EVALUATION, POSITION WITH FLUOROSCOPE IS VERIFIED, INCISION IS MADE, THE FRAGMENT IS REMOVED AND SKIN IS SUTURED. THE HOSPITAL STAY IS NOT PROLONGED OR THE PATIENT'S INITIAL MANAGEMENT PLAN IS CHANGED. HE LEAVES THE INSTITUTION ON THE SAME DAY AND INFORMS THE PATIENT AND FAMILY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901541 NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE ANESTHESIA CONDUCTION NEEDLE BSP BD CARIBE LTD. 9011708 30382904050796

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention