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Patient 1
ROOT CAUSE: THE TRUE ROOT CAUSE HAS BEEN DETERMINED TO BE A CUSTOMER-RELATED SHIPPING ISSUE. THE SCALPELS ARE SHIPPED PER THE CUSTOMER'S SPECIFICATIONS. THE CUSTOMER PROVIDED PHOTOGRAPHS THAT INDICATE THE PACKAGING AND THE PRODUCT SUSTAINED DAMAGE DURING SHIPPING. CORRECTIVE ACTION: DEROYAL WILL CONTINUE TO MONITOR THIS ISSUE. IN AN E-MAIL, THE CUSTOMER INDICATED IT HAS REVISED ITS PALLET DIMENSIONS FOR PRODUCT SHIPMENTS. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED REPORTING THAT, WHEN UNPACKING BOXES OF THE PRODUCT, THE SAFETY SCALPEL BLADES WERE NOT FULLY RETRACTED, WHICH PRESENTED A RISK. THIS REPORT IS NOT BEING FILED WITHIN 30 DAYS OF DEROYAL BECOMING AWARE OF THE EVENT. AS PART OF THE INVESTIGATION, A RETROSPECTIVE REVIEW OF COMPLAINTS WAS CONDUCTED AND THIS REPORT WAS IDENTIFIED AS BEING RELATED TO REPORTS 1060680-2017-00001 AND 1060680-2017-00005. THE INITIAL REPORT INDICATED THAT A SAMPLE WAS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, A SAMPLE HAS NOT BEEN RECEIVED. HOWEVER, THE CUSTOMER PROVIDED PHOTOGRAPHS. THESE PHOTOGRAPHS CONFIRM THE REPORTED ISSUE BUT ALSO INDICATE THE PACKAGING AND THE PRODUCT SUSTAINED DAMAGED DURING SHIPPING. DEROYAL SHIPS THE PRODUCT PER THE CUSTOMER'S SPECIFICATIONS. THE SAFETY SCALPEL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST TO (B)(4). AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. 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.