BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE

    MDR report key: 5259043 · Received December 1, 2015

    Report

    Report Number
    2618282-2015-00008
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    November 4, 2015
    Report Date
    December 4, 2015
    Manufacturer
    BD CARIBE LTD.
    Product Code
    BSP
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - THE SAMPLES WERE RECEIVED BY THE MANUFACTURING SITE FOR ADDITIONAL EVALUATION. A VISUAL EVALUATION OF THE RETURNED SAMPLE SHOWS THAT THE NEEDLE WAS BROKEN. IN ADDITION, THE NEEDLE APPEARS TO BE BENT. A REVIEW OF THE MANUFACTURING PROCESS AND DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5062666. A QUALITY NOTIFICATION REVIEW WAS CONDUCTED FOR THE CANNULA COMPONENT AND NO NCMR'S AND/OR SCARS WERE GENERATED FOR CONDITIONS RELATED TO BROKEN NEEDLE. CONCLUSION - ALTHOUGH AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED, THE QUALITY ENGINEER STATES THAT BASED ON PREVIOUS INVESTIGATIONS AND SAMPLE EVALUATION SHOWING THAT THE NEEDLE WAS BENT, THIS DEFECT COULD POTENTIALLY BE DUE TO ERROR IN USER TECHNIQUE. THIS MAY BE CAUSED BY THE SPINAL NEEDLE BEING BENT OFF AXIS IN SOME MANNER AND WITHDRAWING THE NEEDLE THROUGH THE INTRODUCER, ENGAGING THE SHARP BELL OF THE INTRODUCER NEEDLE AND FRACTURING ON THE POINT OF THE INTRODUCER NEEDLE. ANOTHER POTENTIAL ROOT CAUSE IS EXCESSIVE BENDING AND/OR RESTRAIGHTENING OF THE NEEDLE. NO POSSIBLE CAUSE HAS BEEN IDENTIFIED FOR THIS COMPLAINT RELATED TO THE MANUFACTURING PROCESS. SEE REPORT FOR INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5062666. (B)(4) DEVICE SAMPLES FROM THE REPORTED LOT NUMBER WERE RECEIVED SEALED AND WITHIN THE PACKAGING. ONE USED SAMPLE WITH A FRACTURED NEEDLE WAS RECEIVED WITHIN A SEPARATE CANISTER. THE USED SAMPLE WAS VISUALLY EXAMINED AND WAS CONFIRMED FOR THE STATED DEFECT. CONCLUSION: THIS COMPLAINT IS CONFIRMED BASED ON VISUAL INSPECTION. THE SAMPLES WERE SENT TO THE MANUFACTURING SITE FOR FURTHER INVESTIGATION. SEE REPORT FOR INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION OF A BD¿ WHITACRE NEEDLE, THE MIDDLE OF THE NEEDLE BROKE OFF AND WAS LEFT BETWEEN THE VERTEBRAE IN THE PATIENT'S LOWER BACK. THE PATIENT REQUIRED AN EMERGENCY SURGERY WITH FLUOROSCOPY UNDER GENERAL ANESTHESIA TO REMOVE THE NEEDLE. THE INCISION WAS 7-8 CM LONG BY 7-8 CM DEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786942 27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE ANESTHESIA SPINAL NEEDLE BSP BD CARIBE LTD. 5062666

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention