ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

THE REGULATOR WAS RETURNED, PROMPTING RE-OPENING OF THE COMPLAINT AND AN INVESTIGATION. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. PRODUCT WAS RETURNED FOR TESTING ON THIS INVESTIGATION. A NON-CONFORMANCE-BASED REVIEW OF THE LOT 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 THE BATCH PRODUCTION RECORD FOR THIS LOT, SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED SEVEN OTHER COMPLAINTS AGAINST THESE LOTS. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 31 COMPLAINTS SINCE THE BEGINNING OF 2017. THE REGULATOR WAS TESTED AND FAILED FOR FLOW @ 100 PSI, WITH A RESULT OF 1400 CC/MIN (SPECIFICATION IS 2000 - 4000 CC/MIN.). THE REGULATOR WAS NOT ABLE TO BE ADJUSTED INTO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTES TO A FAULTY REGULATOR. HOW OR WHY THIS REGULATOR BECAME NON-CONFORMING CANNOT BE CONCLUSIVELY DETERMINED, BASED UPON THE INFORMATION PROVIDED 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 CUSTOMER REPORTED THAT DURING A SETUP OF PARS PLANA VITRECTOMY SURGERY, REGULATOR FAILED TO DISPENSE AN OPHTHALMIC GAS FREQUENTLY. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.