BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN HEART PACK

    MDR report key: 5031053 · Received August 26, 2015

    Report

    Report Number
    3005011024-2015-00005
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 26, 2015
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: 1) CALL (B)(4) WAS RECEIVED INDICATING THAT FINISHED GOOD 89-8572, OPEN HEART PACK, CONTAINED A HAIR. 2) THE QC COMPLAINT SPECIALIST FOLLOWED UP WITH THE REPORTING DEROYAL SALES REPRESENTATIVE TO OBTAIN THE LOT NUMBER AFFECTED AND HAIR LOCATION WITHIN THE PACK. INFORMATION RECEIVED DETAILED THAT FINISHED GOOD 89-8572, OPEN HEART PACK, WAS CONTAINED WITHIN FINISHED GOOD 53-1941, OPEN HEART TRACECART, LOT NUMBER 39773414. LOT MAPPING OF FINISHED GOOD 53-1941, LOT NUMBER 39773414, IDENTIFIED THAT IT CONTAINED MULTIPLE LOT NUMBERS, 39283693 AND 39342711, OF FINISHED GOOD 89-8572. 3) BECAUSE THE LOT NUMBER INFORMATION WAS OBTAINED, THE QC COMPLAINT SPECIALIST REVIEWED THE WORK ORDERS FOR FINISHED GOOD 89-8572 LOT NUMBERS 39283693 AND 39342711. THE WORK ORDER REVIEWS DID NOT IDENTIFY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. 4) DEROYAL PERSONNEL PERFORMED AN ONSITE VISIT WITH THE REPORTING CUSTOMER. DURING THIS MEETING, THE REPORTING CUSTOMER IDENTIFIED THAT THE HAIR CONTAMINATION ORIGINATED FROM THE 5-5042, O.R. TOWEL. 5) FINISHED GOOD 89-8572, LOT NUMBER 39283693, CONTAINED RAW MATERIAL 5-5042, LOT NUMBER 11OA15. LOT NUMBER 39342711, CONTAINED RAW MATERIAL 5-5042, LOT NUMBER 11OB08. (B)(4) SUPPLIED THE IDENTIFIED RAW MATERIAL LOT NUMBERS TO DEROYAL. 6) THE QC COMPLAINT SPECIALIST REVIEWED THE 2013-2015, SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER (SNL) LOGS FOR SIMILAR COMPLAINT INFORMATION. INCLUDING THIS REPORT, A TOTAL OF SIX SIMILAR COMPLAINTS WERE IDENTIFIED FOR THE RAW MATERIAL CONTAINING HAIR/DEBRIS CONTAMINATION. AS A RESULT, SCAR2015-283KJG WAS ISSUED ON 8/18/2015. 7) IN 2013, (B)(4) IMPLEMENTED A QUALITY IMPROVEMENT INITIATIVE, WHICH INCLUDED THE ADDITION OF SUCTION EQUIPMENT TO REMOVE HAIR/DEBRIS CONTAMINATION FROM THE O.R. TOWELS. EVIDENCE OF THIS ACTION IS IN THE (B)(4) CLEAN AREA DRESSING ATTACHMENT. 8) COMMUNICATION BETWEEN (B)(4) REPRESENTATIVES AND DEROYAL'S QC COMPLAINT SPECIALIST IDENTIFIED THAT THE LOT NUMBERS REPORTED WERE MANUFACTURED IN JANUARY AND FEBRUARY 2015, WHICH OCCURRED AFTER IMPLEMENTATION OF THE SUPPLIER'S 2013 QUALITY IMPROVEMENT INITIATIVE. 9) (B)(4) RESPONDED TO SCAR2015-283KJG ON 8/24/2015. REFER TO THE SCAR2015-283 CALL (B)(4) ATTACHMENT. THE COMPLAINT WILL BE ASSIGNED FOR VERIFICATION OF EFFECTIVENESS TO VERIFY THE ACTIONS TAKEN AS A RESULT OF THIS COMPLAINT INVESTIGATION. CORRECTION: REPLACEMENTS HAVE BEEN PROVIDED ON ORDER NUMBER (B)(4). ROOT CAUSE ANALYSIS: SCAR: THE BOUFFANT CAP (AS PART OF THE GOWNING PROCEDURE) SHIFTED DURING THE PACKAGING PROCESS AND FAILED TO HOLD/COVER THE PERSONNEL'S HAIR AFTER AN EXTENDED TIME. DEROYAL: THE REPORTED ISSUE WAS DETERMINED TO BE A VENDOR MANUFACTURING ERROR. THIS ERROR WENT UNDETECTED DURING THE INTERNAL VISUAL INSPECTION PROCESS. A POTENTIAL CONTRIBUTING FACTOR TO THE VISUAL INSPECTION OVERSIGHT IS THE HAIR LOCATION WITHIN THE O.R. TOWEL. AT THE TIME/DATE THE FINISHED GOOD WAS MANUFACTURED, DEROYAL PERSONNEL DID NOT SEPARATE THE O.R. TOWELS DURING THE INSPECTION PROCESS. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: SCAR: HAIR NETS HAVE BEEN ADDED TO THE GOWNING REQUIREMENTS AND ARE REQUIRED FOR ALL WORKERS. REVISED AQL SAMPLING SIZE HAS BEEN REQUIRED FOR ALL DEROYAL TOWEL INSPECTIONS FOR THE NEXT THREE MONTHS TO AVOID RECURRENCE. DEROYAL: DETAILED INSPECTION CRITERIA HAVE BEEN ADDED TO THE WORK ORDER ROUTINGS. (B)(4) UPDATED THE "ASSEMBLY ROUTINGS" TO IDENTIFY THAT QUALITY CONTROL (QC) PERSONNEL ARE REQUIRED TO BE PRESENT DURING THE 100% INSPECTION PROCESS. INSPECTIONS OF THE O.R. TOWELS MUST INCLUDE LOOKING FOR HAIR/DEBRIS BETWEEN EACH TOWEL. REFER TO THE FINISHED GOOD 89-8572 ECO INFORMATION ATTACHMENT. ON 8/5/2015, THE QC SUPERVISOR ADDRESSED HAIR RELATED CONTAMINATION WITH ALL MANUFACTURING PERSONNEL. QUALITY CONTROL AND SUPERVISORS ARE PERFORMING DAILY INSPECTION OF EMPLOYEES TO ENSURE THAT HAIR COVERINGS ARE ADEQUATE. IF IT IS IDENTIFIED THAT AN EMPLOYEE'S HAIR IS UNABLE TO BE CONTAINED BY A SINGLE BOUFFANT, INSTRUCTIONS WILL BE PROVIDED TO DO TWO BOUFFANTS. REFER TO THE NOTIFICATION MEMO 89-8572 ATTACHMENT. THE MANUFACTURING FACILITY HAS PLACED RAW MATERIAL(B)(4), O.R. TOWEL, UNDER PURCHASE INSPECTION BEGINNING 8/7/2015. THIS ANSI INSPECTION NEEDS TO BE AT A NORMAL LEVEL. CORPORATE ACTION POINT, CORP. (B)(4) HAS BEEN INITIATED TO ADDRESS THE POTENTIAL CONTAMINATION FROM DEROYAL MANUFACTURING PERSONNEL. PREVENTIVE ACTION: SCAR: MANAGEMENT WILL VERIFY THE IMPLEMENTATION OF THE NEW PROCEDURE INTRODUCED. (HAIR NET; REVISED AQL SAMPLING SIZE.) DEROYAL: A PREVENTIVE ACTION HAS NOT BEEN IMPLEMENTED BY DEROYAL. DEROYAL'S PERSONNEL DRESS CODE PROCEDURE, (B)(4), PROVIDES ADEQUATE WORK INSTRUCTIONS. DEVICE NOT RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    DURING EMERGENCY HEART CASE SETUP WHILE THE PATIENT WAS BEING ROLLED INTO THE OR, NURSE OPENED THE PART B TRAY TO FIND A LONG BLACK HAIR ON TOP OF THE TRAY INSIDE BACK TABLE COVER. THE PATIENT WAS REMOVED FROM THE ROOM AND HAD TO SCRUB ENTIRE ROOM DOWN, ACCORDING TO THE STAFF, DELAYING THE PROCEDURE 30 TO 60 MINUTES. THIS IS THE FOURTH REPORTED HAIR ISSUE. THEY HAVE ACTUALLY HAD FIVE HAIR INCIDENTS THINKING THE FIRST WAS THEIR FAULT AND DID NOT REPORT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565253 OPEN HEART PACK KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 39773414

    Patients

    Seq Age Sex Outcome Treatment
    1