BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTIP

    MDR report key: 9252431 · Received October 29, 2019

    Report

    Report Number
    1058382-2019-00006
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    October 3, 2019
    Report Date
    December 6, 2019
    Manufacturer
    DR. JAPAN CO. LTD.
    Product Code
    BSP
    UDI-DI
    00817781020079
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: INVESTIGATION RESULT: AFTER EXAMINING THE ACTUAL DEVICE RETURNED BY THE END-USER, IT WAS OBSERVED THE NEEDLE CANNULA WAS BENT IN SEVERAL LOCATIONS, AND THERE MULTIPLE SUBSTANCES ATTACHED. A LARGE SCRATCH WAS OBSERVED ON THE CANNULA WHICH MAY HAVE BEEN CAUSED WHEN THE NEEDLE WAS REMOVED FROM THE PATIENT. IT WAS OBSERVED THAT THE HOLE IN THE NEEDLE HUB FROM WHICH THE NEEDLE WAS ATTACHED WAS CIRCULAR AND NO ABNORMALITY WAS FOUND. THERE WAS AN UNIDENTIFIED SUBSTANCE INSIDE THE NEEDLE HUB AT THE ATTACHMENT SITE, BUT AS THE NEEDLE SHAPE REMAINS IT MAY HAVE BEEN CAUSED AFTER THE NEEDLE WAS REMOVED. THE INVESTIGATION WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR THE NEEDLE SEPARATION BY EXAMINING THE RETURNED DEVICE. BATCH RECORDS WERE CHECKED FOR THE SAME LOT AND THE PRODUCT LOT PASSED THE FINAL INSPECTION PULLING TEST. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS ISSUE FOR THIS LOT NUMBER. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED FOR THIS DEVICE FAMILY FOR THE PAST THREE (3) YEARS. AS NO ROOT CAUSE WAS DETERMINED, NO CORRECTIVE ACTION WILL BE TAKEN. THE INVESTIGATION REPORT IS ATTACHED TO THIS REPORT FOR REFERENCE. WE CONSIDER THIS FILE CLOSED. CORRECTED DATA: SECTION D10: DEVICE RETURNED TO THE MANUFACTURER DATE ADDED. SECTION F7: SUPPLEMENTAL REPORT 001 SELECTED. SECTION H10: NARRATIVE AND CORRECTED DATA ADDED. FACTORY INVESTIGATION REPORT WITH ATTACHMENTS ADDED TO FILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DOCTOR WAS USING A 22G X 3 ½" QUINCKE NEEDLE FOR A SACROILIAC JOINT INJECTION AND WHEN SHE WENT TO REMOVE THE NEEDLE FROM THE PATIENT THE PLASTIC HUB SEPARATED FROM THE METAL NEEDLE. AN INCISION WAS MADE TO REMOVE THE NEEDLE FROM THE PATIENT AS THE NEEDLE WAS INSERTED UNDERNEATH THE SURFACE OF THE SKIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DOCTOR WAS USING A 22G X 3 ½" QUINCKE NEEDLE FOR A SACROILIAC JOINT INJECTION AND WHEN SHE WENT TO REMOVE THE NEEDLE FROM THE PATIENT THE PLASTIC HUB SEPARATED FROM THE METAL NEEDLE. AN INCISION WAS MADE TO REMOVE THE NEEDLE FROM THE PATIENT AS THE NEEDLE WAS INSERTED UNDERNEATH THE SURFACE OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044149 ACCUTIP ANESTHESIA NEEDLE BSP DR. JAPAN CO. LTD. LN-81207L 00817781020079

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention