INDEFLATOR

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: ESTIMATED DATE.

Description of Event or Problem

IT WAS REPORTED IN A GENERAL COMMENT THAT THE COPILOT DID NOT SCREW IN PROPERLY AND LEAKED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED AND BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DEVICE WAS MISALIGNED, NOT FULLY CONNECTED OR TIGHTENED, OR THAT THE PORT WAS COMPROMISED, RESULTING IN THE REPORTED LOOSE OR INTERMITTENT CONNECTION; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. H6- CORRECTION MEDICAL DEVICE PROBLEM CODE 1354 WAS REMOVED.