NASOPHARYNGEAL TEMPERAT PROBE, 9 FR, 3" TUBE/FLAT CORD

Additional Manufacturer Narrative

DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, BUT THE DEVICE WAS UNAVAILABLE FOR RETURN AND COULD NOT BE INSPECTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE FOUND WITH THE MANUFACTURING AND INSPECTION PROCESSES. IT WAS CONFIRMED THAT CLEAR INSTRUCTIONS WERE IN PLACE FOR ASSEMBLY OF THE TUBING. THE RISK FILE WAS REVIEWED AND WAS NOT IN NEED OF AN UPDATED. MATERIAL REVIEW REPORTS (MRRS) WERE ALSO REVIEWED AND NO SIMILAR ISSUES HAVE BEEN REPORTED. PRODUCTS IN PROCESS WERE ALSO INSPECTED FOR PART NUMBER 81-025400 AND NO SIMILAR ISSUES WERE IDENTIFIED. (B)(4) OF PRODUCT FROM THE SAME LOT WAS INSPECTED. NO ISSUES WERE IDENTIFIED DURING THE INSPECTION. A COMPLAINT TO SALES RATIO WAS GENERATED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT AVAILABLE FOR RETURN AND NO ISSUES WERE IDENTIFIED IN PRODUCTION RECORDS, NO ROOT CAUSE COULD BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN BECAUSE NO ROOT CAUSE COULD BE DETERMINED. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A USER FACILITY REPORTED, "A NASOPHARYNGEAL TEMPERATURE PROBE COVER WAS RETAINED IN THE PATIENT. POST-OPERATIVELY THE PATIENT COUGHED UP THE 3" PLIABLE PLASTIC PIECE."

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "A NASOPHARYNGEAL TEMPERATURE PROBE COVER WAS RETAINED IN THE PATIENT. POST-OPERATIVELY THE PATIENT COUGHED UP THE 3" PLIABLE PLASTIC PIECE." DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, BUT THE DEVICE WAS UNAVAILABLE FOR RETURN. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.