BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPONGES

    MDR report key: 5188971 · Received October 29, 2015

    Report

    Report Number
    1060680-2015-00044
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    September 3, 2015
    Report Date
    October 29, 2015
    Manufacturer
    CARWILD CORPORATION
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: (B)(4) CORPORATION SUPPLIES THE NEURO SPONGES, WHICH ARE MANUFACTURED AT ITS (B)(4) FACILITY. IN ITS RESPONSE TO DEROYAL'S SUPPLIER CORRECTIVE ACTION REQUEST (SCAR), (B)(4) STATED THE TRUE ROOT CAUSE IS HUMAN ERROR. INTERNAL PROCEDURE (PC3026/REV AG) SECTION 10, STATES, "PACK A 10 PACK OF NEURO INTO A POUCH, WITH THE VISIBLE SIDE OF THE X-RAY TO THE TRANSPARENT PART OF THE POUCH. IF DURING OPERATION THE NEURO PACKING STRIPS IN POUCH IS NECESSARY TO REJECT ANY PIECE, DEPOSIT INTO THE REJECT BIN AND PLACE THE STACK OF NEURO WAS LEFT INCOMPLETE IN A CONTAINER PROVIDED TO RE ORGANIZE THAT STACK OF 10 UNITS LATER." CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: (B)(4) HAS CONDUCTED RETRAINING ON ITS PROCEDURE (PC3026/REV AG) TO EMPHASIZE ACCOUNTABILITY. EVIDENCE OF TRAINING WAS INCLUDED IN ITS SCAR RESPONSE TO DEROYAL. TO VERIFY THE ACTIONS TAKEN, THE PRODUCT HAS BEEN PLACED UNDER PURCHASE INSPECTION AT THE DEROYAL PROCESSING CENTER WHERE IT IS RECEIVED. INVESTIGATION SUMMARY: A COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A NEURO SPONGE PACK (PART NUMBER 30-300) CONTAINED 11 SPONGES INSTEAD OF 10. (B)(4) CORPORATION SUPPLIES THE NEURO SPONGE, WHICH IS MANUFACTURED AT ITS (B)(4) FACILITY. THE QC COMPLAINT SPECIALIST REVIEWED THE 2013-2015 SCAR AND SUPPLIER NOTIFICATION LETTER (SNL) LOGS FOR SIMILAR COMPLAINTS, WHICH WERE IDENTIFIED FOR THE PRODUCT LINE. THEREFORE, A SCAR WAS ISSUED AND WAS RECEIVED 10/07/2015. EVIDENCE OF THE SUPPLIER'S CORRECTIVE ACTIONS WAS RECEIVED 10/09/2015. TO VERIFY THE ACTIONS TAKEN, THE DEROYAL QC COMPLAINT SPECIALIST SUBMITTED A REQUEST TO QUALITY CONTROL AT THE DEROYAL PROCESSING CENTER WHERE THE PRODUCT IS RECEIVED TO PLACE IT UNDER PURCHASE INSPECTION. PREVENTIVE ACTION: (B)(4) HAS INDICATED NO PREVENTIVE ACTIONS WERE TAKEN. THIS INVESTIGATION IS INCOMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THERE WERE 11 SPONGES IN THE PACK INSTEAD OF 10. THE SPONGES WERE GIVEN TO THE CLINICAL EDUCATOR, BUT THE PACKAGING WAS NOT. THEREFORE, NO LOT NUMBER IS AVAILABLE. THE ORIGINAL INTENDED PROCEDURE WAS CERVICAL STENOSIS WITH MYELOPATHY AND RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719715 NEURO SPONGES GAUZE/SPONGE, INTERNAL EFQ CARWILD CORPORATION NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1