SAFETY SCALPEL

Additional Manufacturer Narrative

INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REPORTING THAT, WHEN UNPACKING BOXES OF THE PRODUCT, THE SAFETY SCALPEL BLADES WERE NOT FULLY RETRACTED, WHICH PRESENTED A RISK. THE INITIAL REPORT INDICATED THAT A SAMPLE WAS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED. HOWEVER, A PHOTO HAS BEEN MADE AVAILABLE AND CONFIRMS THE REPORTED ISSUE. THE SAFETY SCALPEL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REPORT WAS ISSUED TO (B)(4). A RESPONSE IS DUE JANUARY 20, 2017. AS OF THE DATE OF THIS REPORT, IT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

DURING THE UNPACKING OF THE BOXES, THE BLADES WERE NOT FULLY RETRACTED, CAUSING DANGER TO THE STAFF.

Additional Manufacturer Narrative

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 ADDITIONAL 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 ((B)(4)) WAS RECEIVED REPORTING THAT, WHEN UNPACKING BOXES OF THE PRODUCT, THE SAFETY SCALPEL BLADES WERE NOT FULLY RETRACTED, WHICH PRESENTED A RISK. THE INITIAL REPORT INDICATED THAT A SAMPLE WAS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED. HOWEVER, A PHOTO HAS BEEN MADE AVAILABLE AND CONFIRMS THE REPORTED ISSUE. ADDITIONAL PHOTOGRAPHS FROM THE CUSTOMER WERE PROVIDED THAT INDICATE THE PACKAGING AND THE PRODUCT SUSTAINED DAMAGE DURING SHIPPING. DEROYAL SHIPS THE PRODUCT PER THE CUSTOMER'S SPECIFICATIONS. THE SAFETY SCALPEL IS SUPPLIED TO DEROYAL BY S&S SURGICAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REPORT WAS ISSUED TO S&S SURGICAL. A RESPONSE WAS RECEIVED JANUARY 13, 2017, AND ACCEPTED JANUARY 20, 2017. 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.

Description of Event or Problem

DURING THE UNPACKING OF THE BOXES, THE BLADES WERE NOT FULLY RETRACTED, CAUSING DANGER TO THE STAFF.

Additional Manufacturer Narrative

ROOT CAUSE: THE SCALPELS ARE SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). IN ITS RESPONSE, (B)(4) STATED IT WAS UNABLE TO DETERMINE THE ROOT CAUSE. THE INITIAL REPORTER DID NOT PROVIDE A LOT NUMBER OR A SAMPLE. HOWEVER, A PHOTO CONFIRMED THE REPORTED ISSUE. DEROYAL HAS DETERMINED A POTENTIAL ROOT CAUSE OF A SHIPPING-RELATED ISSUE. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) STATED IT WILL CONTINUE TO REVIEW THE PROCESS. DEROYAL HAS PUT THE RAW MATERIAL ON INCOMING INSPECTION AND WILL INSPECT THE NEXT THE SHIPMENT RECEIVED FOR THE REPORTED ISSUE. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REPORTING THAT, WHEN UNPACKING BOXES OF THE PRODUCT, THE SAFETY SCALPEL BLADES WERE NOT FULLY RETRACTED, WHICH PRESENTED A RISK. THE INITIAL REPORT INDICATED THAT A SAMPLE WAS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED. HOWEVER, A PHOTO HAS BEEN MADE AVAILABLE AND CONFIRMS THE REPORTED ISSUE. THE SAFETY SCALPEL IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REPORT WAS ISSUED TO (B)(4). A RESPONSE WAS RECEIVED JANUARY 13, 2017, AND ACCEPTED JANUARY 20, 2017. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN.

Description of Event or Problem

DURING THE UNPACKING OF THE BOXES, THE BLADES WERE NOT FULLY RETRACTED, CAUSING DANGER TO THE STAFF.