ISPAN GAS TANK REGULATOR
Received Aug 30, 2023
Report 2518435-2023-00029 · MDR key 17650876
Device
Generic name
Regulator, Pressure, Gas Cylinder
Manufacturer
Airgas Therapeutics LlcModel number
NACatalog number
8065797303
Lot number
105514
Product problems
- No Flow
- No Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED SCHEDULED PROCEDURE WAS CATARACT AND VITRECTOMY COMBINATION.
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 OPHTHALMIC GAS TANK VALVE NOT MEASURING THE VOLUME CONTAINED AND NOT RELEASING THE GAS FOR USE, EVEN WITH A FULL TORPEDO. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Additional Manufacturer Narrative
A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED ONE OTHER COMPLAINT AGAINST THIS LOT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 25 COMPLAINTS SINCE THE BEGINNING OF 2016. THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. THERE WAS NO SAMPLE RETURNED FOR THIS INVESTIGATION. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT CONFIRMED. 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)