ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. A REGULATOR WAS RETURNED ON THIS INVESTIGATION. A NON-CONFORMANCE BASED REVIEW OF THE LOT NUMBER WAS PERFORMED AND A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED COMPLAINT WAS IDENTIFIED. A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A TOTAL OF 77 REGULATORS WERE RELEASED IN THIS LOT. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT WAS PERFORMED. A POTENTIALLY RELEVANT COMPLAINT WAS FOUND AND REVIEWED AS PART OF THIS COMPLAINT. AIRGAS TEAM PERFORMED A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 39 COMPLAINTS SINCE THE BEGINNING OF 2017. ONE REGULATOR WAS RECEIVED FOR THIS INVESTIGATION, IN GOOD CONDITION. THE REGULATOR WAS TESTED AND PASSED FOR FLOW WITH 3700 CC/MIN (SPECIFICATION IS 2000-4000 CC/MIN). HOWEVER, THE REGULATOR FAILED FOR DEAD END PRESSURE AT 320 POUNDS PER SQUARE INCH (PSI), IT WAS ALLOWING 10.50 PSI AND RISING TO FLOW THROUGH (SPECIFICATION IS <10 PSI). HOW OR WHY THE REGULATORS BECAME NONCONFORMING IS INCONCLUSIVE BASED ON THE INFORMATION OBTAINED AT THIS TIME. A NON CONFORMANCE INVESTIGATION WAS OPENED TO ADDRESS THE ISSUE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE ISPAN REGULATOR NOT RELEASING GAS CAN BE ATTRIBUTED TO FAULTY REGULATORS. HOW OR WHY THE REGULATORS BECAME NONCONFORMING IS INCONCLUSIVE BASED ON THE INFORMATION OBTAINED AT THIS TIME. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NURSE REPORTED THAT NO GAS CAME OUT OF REGULATOR DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. DETAILS OF SURGERY WAS NOT REPORTED.