MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: A REVIEW OF THE PRODUCTION RECORDS REVEALED NO MANUFACTURING-RELATED DEVICE SPECIFICATION DEVIATIONS. PRIOR TO PACKING, ALL UNITS UNDERWENT VISUAL INSPECTION AND A LEAK TEST AFTER BEING MANUFACTURED. ANY PRODUCT THAT IS DISCOVERED TO BE LEAKING IS IMMEDIATELY REMOVED FROM THE LINE AND DISPOSED OF APPROPRIATELY. THERE WERE NO PROBLEMS IDENTIFIED DURING A REVIEW OF THE BATCH PAPERWORK FOR LOT L01A-01319 THAT COULD BE CONNECTED TO DAMAGE FAILURES ON THESE BATCHES. THE CANISTER WAS VISUALLY INSPECTED AND TESTED FOR LEAKS BEFORE BEING DELIVERED BACK TO MPL FOR FURTHER EXAMINATION. THE RETAIN SAMPLE HAS NO OBVIOUS VISUAL DAMAGE AND PASSED THE LEAK TEST WITH NO ISSUES FOUND. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

H3: 81 OTHER ¿ 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, MULTI ABSORBER CANISTER HAD A LEAK DURING PATIENT USE. NO HARM IS ASSOCIATED WITH THE EVENT.