BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO PATTIE

    MDR report key: 5900639 · Received August 24, 2016

    Report

    Report Number
    1060680-2016-00024
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    June 29, 2016
    Report Date
    October 26, 2016
    Manufacturer
    CARWILD CORP.
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: MEDWATCH REPORT (B)(4) WAS RECEIVED JULY 26, 2016, AND ENTERED AS CALL (B)(4). ACCORDING TO THE MEDWATCH REPORT, A NEURO PATTIE BECAME DETACHED FROM ITS LOCATOR STRING AND WAS UNABLE TO BE LOCATED. THE SPONGE IS SUPPLIED TO DEROYAL BY (B)(4). AS SUCH, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE SUPPLIER'S MANUFACTURING FACILITY, (B)(4). THE REPORTING CUSTOMER HAS BEEN CONTACTED REGARDING SAMPLE AVAILABILITY.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE NEURO PATTIE IS SUPPLIED TO DEROYAL INDUSTRIES, INC. BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO (B)(4). IN ITS SCAR RESPONSE, THE SUPPLIER STATED THE REPORTED ISSUE COULD HAPPEN DUE TO THE MEDICAL STAFF ATTEMPTING TO REMOVE THE PATTIE BY THE STRING. IN THE IFU, IT STATES, "THE STRING IS ATTACHED TO THE SPONGE FOR LOCATION OR IDENTIFICATION PURPOSES ONLY. DO NOT USE THE STRING TO REMOVE THE SPONGE FROM THE WOUND." CORRECTION: IN ITS SCAR RESPONSE, (B)(4) STATED ALL PERSONNEL INVOLVED (SUPERVISOR, GROUP LEADER AND COLLABORATORS) WERE NOTIFIED ABOUT THE REPORTED ISSUE FOR AWARENESS DURING THE PROCESS. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY MEDWATCH REPORT (B)(4) WAS RECEIVED JULY 26, 2016, AND ENTERED AS (B)(4). ACCORDING TO THE MEDWATCH REPORT, A NEURO PATTIE BECAME DETACHED FROM ITS LOCATOR STRING AND WAS UNABLE TO BE LOCATED. THE REPORTING CUSTOMER RETURNED A REPRESENTATIVE SAMPLE FROM THE SAME LOT FOR EVALUATION. DEROYAL PURCHASES THE NEURO PATTIES FROM (B)(4). A SCAR AND THE SAMPLE RETURNED BY THE CUSTOMER WERE SENT TO (B)(4) FOR REVIEW. ACCORDING TO THE SCAR, THE SUPPLIER'S INVESTIGATION SHOWED THE WORK ORDER WAS COMPLETED ACCORDING TO CURRENT PROCEDURE AND CUSTOMER REQUIREMENTS. DEROYAL REVIEWED TWO CASES OF INVENTORY. NO CASES FROM THE REPORTED LOT NUMBER WERE AVAILABLE. SAMPLES WERE COUNTED TO ENSURE PROPER COUNT, PULLED ON, AND SOAKED WITH SALINE THEN PULLED ON. NO REJECTS WERE IDENTIFIED. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    NEURO SPONGE WAS MISSING FROM THE END OF THE ATTACHED STRING AT COMPLETION OF A SURGICAL PROCEDURE. ROOM CHECKED, SURGICAL FIELD SEARCHED. SPECIAL ATTENTION PAID TO SURGICAL SITE, X-RAY TAKEN AND THE SPONGE WAS NEVER LOCATED. IN DISCUSSION WITH STAFF, IT IS REPORTED THESE SPONGES BECOME LOOSE ON STRING WHEN THEY ARE SATURATED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? L3-L5 REVISION, L5-S1 DECOMPRESSION.

    Description of Event or Problem · 1

    NEURO SPONGE WAS MISSING FROM THE END OF THE ATTACHED STRING AT COMPLETION OF A SURGICAL PROCEDURE. ROOM CHECKED, SURGICAL FIELD SEARCHED. SPECIAL ATTENTION PAID TO SURGICAL SITE, X-RAY TAKEN AND THE SPONGE WAS NEVER LOCATED. IN DISCUSSION WITH STAFF, IT IS REPORTED THESE SPONGES BECOME LOOSE ON STRING WHEN THEY ARE SATURATED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: L3-L5 REVISION, L5-S1 DECOMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552116 NEURO PATTIE GAUZE/SPONGE, INTERNAL EFQ CARWILD CORP. 15E1947

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR