MEDISORB EX, PKG OF 6 PCS

Additional Manufacturer Narrative

DEVICE EVALUATION: G3, G6, H2, H3, H6 AND H10. RESULT OF INVESTIGATION: THE SUSPECT DEVICE WAS RETURNED FOR PRODUCT EVALUATION. ALL UNITS PACKED PASSED 100% LEAK TEST AND VISUAL INSPECTION. REVIEW OF THE BATCH DOCUMENTATION UNDER LOT L01A-01173 FOUND NO ISSUES THAT COULD BE LINKED WITH DAMAGE FAILURES ON THESE BATCHES. THE CALCIUM CARBONATE CONTENT WAS WELL WITHIN SPECIFICATION OF UNUSED MATERIAL (<4.1%) AND SHOULD HAVE BEEN ABLE TO PERFORM AS INTENDED. AFTER THE DEVICE WAS TESTED, IT WAS FOUND ON THE DECONTAMINATION FORM THAT THE DEVICE LID WAS BROKEN WHICH MAY HAVE CAUSED LEAKAGE IN THE SYSTEM AND WHY IT COULD NOT PERFORM AS INTENDED. PALLET AND CARTON FOR CANISTERS CLEARLY STATES THAT THEY ARE FRAGILE AND TO HANDLE WITH CARE. DEVICES ARE PACKAGED IN A CARTON THAT MEETS THE VYAIRE DROP TESTING SPECIFICATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE MEDISORB¿ EX, DISPOSABLE CANISTER CANNOT ABSORB CARBON DIOXIDE. THE SAID ISSUE OCCURRED DURING SURGERY AND THE CUSTOMER CONFIRM NO HARM WAS DONE TO THE PATIENT.