3 P RH "B" SP CLR ON 3W MFLD

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "LEAKAGE DURING CLINICAL USE." THREE INSTANCES OF THIS ISSUE WERE REPORTED FOR THIS PART NUMBER. THIS IS REPORT 2 OF 3. IT WAS PREVIOUSLY REPORTED THAT A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WOULD BE SENT, HOWEVER, AFTER FURTHER INVESTIGATION, IT WAS DETERMINED TO NOT BE A VENDOR ISSUE, AND NO SCAR WAS SENT. DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, AND IT WAS RECEIVED ON MARCH 31, 2025. DEROYAL INDUSTRIES, INC. REVIEWED SPECIFICATIONS AND WORK ORDERS FOR MANIFOLDS RELATED TO THE SAMPLES AND NO ISSUES WERE FOUND. WITHIN THE REVIEWED WORK ORDERS, IT WAS FOUND THAT EACH FUNCTIONAL TEST INCLUDING THE TORQUE TEST, VACUUM LEAK TEST, AND HYDROSTATIC TESTS ALL MET THE RESPECTIVE PARAMETERS. THE FINAL VISUAL 100% INSPECTION WAS ALSO REVIEWED, AND THE PRODUCTS MET ALL ACCEPTANCE CRITERIA. AN INVENTORY CHECK WAS ALSO PERFORMED ON 8 MANIFOLDS THAT WERE PRESENT IN INVENTORY AND ALL WERE WITHIN SPECIFICATION. FAILURE MODES AND EFFECTS ANALYSIS (FMEA) AND CORRECTIVE AND PREVENTIVE ACTIONS RELATED TO THIS ISSUE WERE REVIEWED AND NO ISSUES WERE FOUND. SAMPLES WERE RECEIVED AND TESTED. EACH OF THE SAMPLES MET ALL TESTING REQUIREMENTS AND WERE ALL WITHIN SPECIFICATIONS FOR THREAD THICKNESS AND FEMALE THREAD DIAMETER. A COMPLAINT TO SALES RATIO WAS CONDUCTED BETWEEN JANUARY 2023 TO APRIL 2025 AND FOUND TO BE (B)(4). ROOT CAUSE: BASED ON THE EVALUATIONS AND TESTING PERFORMED, THE ISSUE COULD NOT BE REPRODUCED OR CONFIRMED ON THE SAMPLES RETURNED. ALL SAMPLES WERE WITHIN ALL ACCEPTANCE CRITERIA. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ISSUE COULD NOT BE CONFIRMED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. 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.

Additional Manufacturer Narrative

A USER FACILITY REPORTED, ""LEAKAGE DURING CLINICAL USE." THREE INSTANCES OF THIS ISSUE WERE REPORTED FOR THIS PART NUMBER. THIS IS REPORT 2 OF 3. DEROYAL INDUSTRIES REQUESTED RETURN OF THE DEVICE, HOWEVER IT HAS NOT YET BEEN RETURNED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A USER FACILITY REPORTED, "LEAKAGE DURING CLINICAL USE."