BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SPINAL ¿ NEEDLE 26GA 3-1/2IN

    MDR report key: 8014914 · Received October 29, 2018

    Report

    Report Number
    9610048-2018-00174
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    September 21, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    MIA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER 5240120 FOR (B)(4) WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. A PRODUCTION HISTORY REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION NOR ASSEMBLY OR THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE BROKEN WITH LOT #5240120 REGARDING ITEM (B)(4). AS NO PICTURE NOR PHYSICAL SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. DURING THE MANUFACTURING PROCESS, REGULAR INSPECTIONS ARE PERFORMED TO ENSURE THAT THE PRODUCT IS WITHIN SPECIFICATIONS. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. REPEATED REPOSITIONING OF THE NEEDLE MAY INCREASE THE LIKELIHOOD OF NEEDLE BREAKAGE. THE DEFECT DOES NOT SEEM TO BE RELATED TO MANUFACTURING PROCESS. THIS ISSUE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT NUMBER 5240120 FOR PRODUCT CODE 408380 WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. A PRODUCTION HISTORY REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION NOR ASSEMBLY OR THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE BROKEN WITH LOT #5240120 REGARDING ITEM #408380. AS NO PICTURE NOR PHYSICAL SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. DURING THE MANUFACTURING PROCESS, REGULAR INSPECTIONS ARE PERFORMED TO ENSURE THAT THE PRODUCT IS WITHIN SPECIFICATIONS. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. REPEATED REPOSITIONING OF THE NEEDLE MAY INCREASE THE LIKELIHOOD OF NEEDLE BREAKAGE. THE DEFECT DOES NOT SEEM TO BE RELATED TO MANUFACTURING PROCESS. THIS ISSUE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SPINAL NEEDLE 26GA 3-1/2IN BROKE DURING USE. AN INCISION AND AN ¿IMAGE ENHANCER¿ WAS USED TO REMOVE A FRAGMENT OF THE BROKEN NEEDLE. NO FURTHER MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SPINAL NEEDLE 26GA 3-1/2IN BROKE DURING USE. AN INCISION AND AN ¿IMAGE ENHANCER¿ WAS USED TO REMOVE A FRAGMENT OF THE BROKEN NEEDLE. NO FURTHER MEDICAL INTERVENTION WAS REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SPINAL ¿ NEEDLE 26GA 3-1/2IN BROKE DURING USE. AN INCISION AND AN ¿IMAGE ENHANCER¿ WAS USED TO REMOVE A FRAGMENT OF THE BROKEN NEEDLE. NO FURTHER MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853662 BD SPINAL ¿ NEEDLE 26GA 3-1/2IN SPINAL NEEDLE MIA BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5240120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention