BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASC VASCULAR PACK PGYBK

    MDR report key: 5742723 · Received June 22, 2016

    Report

    Report Number
    3005011024-2016-00010
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    February 11, 2016
    Report Date
    July 19, 2016
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS INCOMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE AFFECTED RAW MATERIAL ((B)(4)) IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO (B)(4). THE TRUE ROOT CAUSE IS A VISUAL INSPECTION FAILURE TO REMOVE THE GAUZE CONTAINING SEWN CONNECTIONS FROM THE PRODUCTION LINE. CORRECTIVE ACTION: THE SUPPLIER STATED IN ITS SCAR RESPONSE THAT WORKERS ARE REQUIRED TO IDENTIFY THE SEWN CONNECTIONS WITH COLOR ADHESIVE TAPES TO AID IN VISUAL DETECTION. INVESTIGATION SUMMARY: A COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT (B)(4) (LOT NUMBER 4070983) CONTAINED A GAUZE WITH SMALL PIECES OF GAUZE SPONGE INSIDE. THE COMPLAINT WAS RECEIVED THROUGH (B)(4). THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. THE WORK ORDER CONTAINED RAW MATERIAL (B)(4) (LOT NUMBER GS1507B13). THIS RAW MATERIAL LOT WAS SUPPLIED BY (B)(4). THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. NONE WERE IDENTIFIED AS RECEIVED FOR THE VENDOR AND FAILURE MODE REPORTED, BUT DUE TO THE NATURE OF THE COMPLAINT, A SCAR WAS ISSUED TO (B)(4). THE SUPPLIER RESPONDED JULY 13, 2016. PREVENTATIVE: THE SUPPLIER STATED IN ITS SCAR RESPONSE THAT RELATED PERSONNEL WERE NOTIFIED AND RETRAINED ON THE APPROPRIATE QUALITY STANDARD AND OPERATING PROCEDURE TO ENHANCE QUALITY AWARENESS AND OPERATING SKILL. THE SUPPLIER ALSO CONTACTED THE RAW MATERIAL SUPPLIER TO ADVISE IT TO TIGHTEN CONTROL ON THE SEWN CONNECTIONS. THIS INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    AFTER RECEIVING A 4X4 SPONGE FROM THE SURGICAL FIELD, THE SCRUB TECH OPENED THE SPONGE TO FIND SEVERAL SMALL PIECES OF GAUZE SPONGE INSIDE. NO CUTTING FROM THE ORIGINAL SPONGE WAS NOTED. THE SPONGE HAD NOT BEEN USED ON THE OPEN FIELD. THE WOUND WAS CHECKED AND IRRIGATED. NO PIECES SEEN. SPONGES WERE FROM DEROYAL VASCULAR PACK.

    Description of Event or Problem · 1

    AFTER RECEIVING A 4X4 SPONGE FROM THE SURGICAL FIELD, THE SCRUB TECH OPENED THE SPONGE TO FIND SEVERAL SMALL PIECES OF GAUZE SPONGE INSIDE. NO CUTTING FROM THE ORIGINAL SPONGE WAS NOTED. THE SPONGE HAD NOT BEEN USED ON THE OPEN FIELD. THE WOUND WAS CHECKED AND IRRIGATED. NO PIECES SEEN. SPONGES WERE FROM DEROYAL VASCULAR PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395613 ASC VASCULAR PACK PGYBK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 40790983

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR