ISPAN GAS TANK REGULATOR
Received Nov 3, 2023 · Event occurred Oct 6, 2023
Report 2518435-2023-00041 · MDR key 18062775
Device
Generic name
Regulator, Pressure, Gas Cylinder
Manufacturer
Airgas Therapeutics LlcModel number
NACatalog number
8065797303
Lot number
224915
Product problems
- Gas Output Problem
- Gas Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 PHYSICIAN REPORTED THAT DURING SURGERY AN OPHTHALMIC REGULATOR DID NOT RELEASE GAS. SURGERY WAS COMPLETED.
Additional Manufacturer Narrative
A SERVICE RECORD REVIEW WAS NOT PERFORMED. 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. 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 FOUR OTHER COMPLAINTS AGAINST THIS LOT. THREE OF THESE WERE FOR CONTROL KNOB ISSUES AND THE FOURTH WAS FOR A LEAKING UNIT. A CHECK OF CONFIRMED COMPLAINTS FOR REGULATORS WITH LOW OR NO FLOW SHOWED 27 COMPLAINTS . THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. NO SAMPLE WAS RETURNED FOR EVALUATION. 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 AT THIS TIME. BASED UPON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED 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
UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTED INFORMATION WAS INCLUDED IN SECTION D.4. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).