ISPAN GAS TANK REGULATOR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN SECTIONS D.9. H.3. H.6. AND H.10. 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 THE LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED THIRTEEN PREVIOUS COMPLAINTS AGAINST THE LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 28 COMPLAINTS SINCE THE BEGINNING OF 2016. ONE REGULATOR OF LOT WAS RETURNED IN GOOD CONDITION. THE REGULATOR WAS TESTED AND PASSED ALL SPECIFICATIONS. BASED UPON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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 AN OPHTHALMIC GAS CYLINDER REGULATOR WAS NOT WORKING. THE OPERATING STAFF CAN HEAR THE GAS BUT NOT FLOWING THROUGH THE OPHTHALMIC REGULATOR. A NEW REGULATOR WAS APPLIED TO THE CYLINDER AND THAT WORKED FINE. THE DETAILS OF PATIENT IMPACT WAS NOT REPORTED.