This is an ongoing investigation involving quality, production, engineering, marketing, sales and the customer.There is a continuation of complaints from this customer on 1500cc flex¿ canister w/valve exhibited damage to the on/off valve.A review of the manufacturing device history record for the referenced lot number was conducted.This investigation determined that all products were manufactured, inspected, and released in accordance with our established specifications for quality and efficacy.Samples were provided by the customer, and a visual examination was completed by engineering, quality and production personnel regarding the breakage of the hardware components.The breakage is visible, and the team believes it is due to the use of contraindicated cleaners, which would weaken the polycarbonate material.The current ifu states cleaning processes allowed.Additionally, our polycarbonate vendor literature also does not recommend the use of polycarbonate material with benzene (phenols) stating that these solvents will cause crazing or cracking.It is cardinal health's position that repeated chlorinated hydrocarbon solvent cleaning might cause the polycarbonate material to relieve internal stress.Chlorinated benzene-based hydrocarbon germicidal / cleaning / disinfecting products per manufacturer's literature, or other harsh solvents are not recommended to be used on the polycarbonate hard canister system.These cleaning agent's literature further states that this is a cleaner for "hard surfaces only".The polycarbonate material that is utilized for our hardware items does not represent a non-porous surface.Per marketing evaluation, the medi-vac® suction outer canisters and ancillary roll stands, and holders should be cleaned with warm soapy water, ethanol, isopropanol, or bleach (naoci).Normally the frequency of the cleaning is dictated by the hospital policy.Based on the information provided by the customer, and the ongoing discussions the manufacturing personnel have with the cardinal health sales team assigned this customer, the assignable cause at this time is customer misuse.Corrective action currently includes discussions of a customer visit by engineering and/or quality representatives from the site.Trending for the past 3 calendar years, indicates these sole customer multiple complaints are the first complaints of on/off valve breakage to part number 65651-616.
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