ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THEY HAD AN ISSUE WHERE THERE WAS AN ¿INABILITY TO PUSH SULPHUR HEXAFLUORIDE( SF6) GAS INTO THE SYRINGE WITHOUT ASSISTANCE GAS WOULD NOT PUSH SYRINGE.¿ THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THERE WAS NO PRODUCT RETURNED ON THIS INVESTIGATION. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. A NON-CONFORMANCE BASED REVIEW OF THE SERIAL NUMBER WAS PERFORMED AND DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT. 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 REVIEW FOR COMPLAINTS REPORTED AGAINST THIS LOT NUMBER WAS PERFORMED. NO SIMILAR COMPLAINTS WERE REPORTED FOR THE PRODUCT LOT UNDER INVESTIGATION. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS THAT FAILED 10 PUSH GAS INTO THE SYRINGE WITHOUT ASSISTANCE FOUND NO COMPLAINTS.. BASED UPON THE INFORMATION PROVIDED, THE REPORTED EVENT WAS DETERMINED TO BE CUSTOMER ERROR. THE DIRECTIONS FOR USE SECTION OF THE PAMPHLET SUPPLIED STATES "IF THE PRESSURE OF THE GAS FROM THE REGULATOR IS NOT SUFFICIENT TO PASSIVELY DISPLACE THE SYRINGE PLUNGER, GENTLY PULL BACK ON THE PLUNGER TO ASSIST FILLING THE SYRINGE WITH GAS." BASED UPON THE INFORMATION PROVIDED, THE REPORTED EVENT WAS DETERMINED TO BE CUSTOMER ERROR. 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

UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION WAS INCLUDED IN SECTION D.4. 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 CUSTOMER REPORTED THAT REGULATORS HAD ISSUES AND THEIR INABILITY TO PUSH SF6 GAS INTO THE SYRINGE WITHOUT ASSISTANCE/GAS WOULD NOT PUSH SYRINGE PLUNGER WHILE ATTEMPTING TO FILL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.