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The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿incorrect/missing translation; missing instructions, vendor/printer error".However, there was insufficient information to confirm this potential root cause.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "prior to cleaning: use personal protective equipment (e.G.Gloves, gowns, eyewear, face masks or shields, respiratory protection devices) appropriately to protect users from exposure to both chemicals and microorganisms.Caution: after use, devices may be a potential biohazard.Handle in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Between uses, the devices should be cleaned manually (includes pre-soak, brushing, rinsing, and drying), visually examined, and sterilized per the instructions below.Note: if the device does not have an inner lumen (e.G.Stylets), instructions pertaining to inner lumens may be disregarded.Manual cleaning: timing ¿ clean medical device as soon as practical after use (e.G.At the point of use) to prevent soiled materials from drying on the devices.Dried or baked materials on the instrument make the removal process more difficult.Point of use pre-cleaning ¿ remove excess soil with cool (maximum 25°c, 77°f) running potable tap water.While rinsing, actuate the device and use a clean, soft bristle brush to brush for a minimum of one (1) minute.For lumen devices, the brush should be the equivalent diameter and length as the lumen¿s diameter and length.Cleaning: cleaning solution - prepare, use, and rinse an enzymatic detergent solution according to manufacturer¿s instructions.Enzol or cidezyme enzymatic detergent was validated with these devices using 1oz per gallon of warm potable tap water (27°c to 44°c, 81°f to 111°f).1 if using an equivalent enzymatic detergent solution, refer to manufacturer¿s instructions for dilution and water temperatures.Water temperature should not exceed 45°c (113°f) for any step of this cleaning process.Presoak - completely immerse the device in the enzymatic detergent solution for a minimum of one (1) minute.Allow the detergent solution to fill all components by manipulating the device.Actuate and brush - after soaking, actuate and brush the device to clean all internal and external surfaces.The brush should be a clean, soft bristle brush with an equivalent diameter and length as the lumen, if applicable.Flush the device with a minimum of 50 ml of detergent solution with a syringe of an appropriate size.Repeat the flush process nine (9) times for a total of ten (10), ensuring all fluid is clear of visible soil and debris.If visible soil is detected during the final lumen flush, repeat brushing and flushing of the lumen steps.Rinsing ¿ rinse the device thoroughly under warm running potable tap water with a temperature range of 27°c to 44°c (81°f to 111°f) for a minimum of one (1) minute to remove any residual detergent or debris.For lumen devices, use a syringe of an appropriate size to flush the lumen with a minimum of 50 ml of warm potable tap water with a temperature range of 27°c to 44°c (81°f to 111°f).Repeat the flush process twice for a total of three (3) times.Drying: dry the device with a clean, lint-free cloth.Visual inspection: examine each device for cleanliness.If visible soil remains, repeat manual cleaning instructions.For devices that fail visual inspection after multiple cleaning attempts, handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations for disposal of biohazardous waste.Devices have been validated for manual cleaning per the instructions provided.Any deviations from the recommended parameters must be validated by the user.Verify that devices are free of deformations (e.G.Bent, broken, corroded, cracked, worn, or fractured) that may impact its intended use.Do not use the device if it is damaged or defective.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Corrosion will lead to rust on stainless steel.Rust particles can be transferred to other instruments.Therefore, devices should be removed from service to prevent formation of rust on other instruments.Sterilization conditions: device should be sterilized in accordance with manufacturer¿s directions using the sterilization cycle parameters below.Ensure device is clean and dry.Device should be placed inside a sterilization tray according to the manufacturer¿s directions.Device should be double wrapped with hospital sterilization wrap.When sterilizing multiple instruments in one autoclave cycle, ensure that the sterilizer¿s maximum load is not exceeded.Allow the device to cool to room temperature after sterilization prior to use.Devices have been validated per the instructions provided.Any deviations from the recommended sterilization parameters must be validated by the user.Storage and replacement: store devices in a dry and clean environment.Contact c.R.Bard, inc.To replace devices as necessary: (b)(4) or email: (b)(4).H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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