ISPAN GAS TANK REGULATOR
Received Jan 22, 2024 · Event occurred Dec 21, 2023
Report 2518435-2024-00004 · MDR key 18551004
Device
Generic name
Regulator, Pressure, Gas Cylinder
Manufacturer
Airgas Therapeutics LlcModel number
NACatalog number
8065797303
Lot number
229210
Product problems
- Gas Output Problem
- Gas Output Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
A CUSTOMER REPORTED THAT THE GAS WAS NOT EMITTED FROM AN OPHTHALMIC REGULATOR AFTER OPENING THE SCREW KNOBS. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED.
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).
Additional Manufacturer Narrative
ADDITIONAL INFORMATION PROVIDED IN SECTIONS H.6. AND H.10. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. NO PRODUCT WAS RETURNED. BASED UPON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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 CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A TOTAL OF SIXTY-FOUR REGULATORS WERE RELEASED FOR THIS LOT. A CHECK OF THE COMPLAINT RECORDS SHOWED TWO OTHER COMPLAINTS AGAINST LOT EACH FOR BLACK KNOB RELATED ISSUES). A CHECK OF CONFIRMED COMPLAINTS FOR CONTROL KNOB PROBLEMS SHOWED 17 COMPLAINTS SINCE THE BEGINNING OF 2017. THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. NO ADDITIONAL INFORMATION WAS OBTAINED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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).