BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP CHOLE PACK

    MDR report key: 6680138 · Received June 30, 2017

    Report

    Report Number
    3005011024-2017-00009
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    May 23, 2017
    Report Date
    February 21, 2018
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    FDE
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE DRAPE CONTAINED WITHIN THE FINISHED GOOD KIT (89-6201) IS SUPPLIED TO DEROYAL BY (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). THE VENDOR RESPONDED INDICATING THE FOAM REINFORCEMENT MATERIAL AROUND THE FENESTRATION NEEDED TO BE CHANGED. IT HAS CHANGED THIS MATERIAL TO A MORE DURABLE FIBER. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) STATED IT IS CHANGING ITS SPECIFICATIONS FOR THE FOAM REINFORCEMENT MATERIAL. (B)(4) HAS DOCUMENTED THIS ISSUE FOR TRENDING AND WILL CONTINUE TO MONITOR THE SITUATION IN ITS CAPA PROGRAM. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL 41062) WAS RECEIVED INDICATING THAT THE FOAM BORDER AROUND THE FENESTRATION OF A DRAPE CONTAINED WITHIN A CONVENIENCE KIT (FINISHED GOOD 89-6201) WAS FLAKING OFF INTO THE SURGICAL SITE. THE DEFECTIVE SAMPLE WAS RETURNED FOR EVALUATION AND RECEIVED JUNE 29, 2017. DEROYAL QUALITY CONTROL PERSONNEL EVALUATED THIS SAMPLE AND CONFIRMED THE DRAPE BORDER WAS FLAKING. THE RETURNED SAMPLE WAS FORWARDED TO (B)(4) FOR REVIEW. HOWEVER, THE VENDOR STATED THE SAMPLE WAS LOST AND THEREFORE PHOTOS OF THE DEFECT WERE PROVIDED TO (B)(4). THE WORK ORDER FOR THE REPORTED FINISHED GOOD LOT WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. AN INVENTORY CHECK COULD NOT BE COMPLETED BECAUSE DEROYAL NO LONGER KEEPS THIS COMPONENT (5-18466-D) ON HAND. THE LAST FINISHED GOOD PRODUCED WITH THIS RAW MATERIAL WAS MANUFACTURED IN JUNE 2016. THE DRAPE CONTAINED WITHIN THE FINISHED GOOD KIT IS SUPPLIED TO DEROYAL BY (B)(4). A SCAR WAS ISSUED TO (B)(4) AND A RESPONSE HAS BEEN RECEIVED. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. NO SIMILAR COMPLAINTS WERE IDENTIFIED FOR THE AFFECTED RAW MATERIAL. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT THE FOAM BORDER AROUND THE FENESTRATION OF A DRAPE CONTAINED WITHIN A CONVENIENCE KIT (FINISHED GOOD (B)(4)) WAS FLAKING OFF INTO THE SURGICAL SITE. THE DEFECTIVE SAMPLE WAS RETURNED FOR EVALUATION AND RECEIVED JUNE 29, 2017. THE DRAPE CONTAINED WITHIN THE FINISHED GOOD KIT IS SUPPLIED TO DEROYAL BY (B)(4). THE DEFECTIVE SAMPLE AND A SUPPLIER CORRECTIVE ACTION REQUEST HAVE BEEN ISSUED TO (B)(4). THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE FOAM BORDER AROUND THE FENESTRATION IN THE LAP DRAPE WAS FLAKING OFF INTO THE SURGICAL SITE, WHICH REQUIRED REPLACING THE DRAPE. THIS CAUSED A 15-MINUTE DELAY ALONG WITH FEAR THAT THE SURGICAL SITE WAS CONTAMINATED WITH FOAM FLAKES.

    Description of Event or Problem · 1

    THE FOAM BORDER AROUND THE FENESTRATION IN THE LAP DRAPE WAS FLAKING OFF INTO THE SURGICAL SITE, WHICH REQUIRED REPLACING THE DRAPE. THIS CAUSED A 15-MINUTE DELAY ALONG WITH FEAR THAT THE SURGICAL SITE WAS CONTAMINATED WITH FOAM FLAKES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463733 LAP CHOLE PACK LAPAROSCOPY KIT FDE DEROYAL INDUSTRIES, INC. 89-6201 41894522

    Patients

    Seq Age Sex Outcome Treatment
    1