The customer reported while completing a flow cell rinse on the cell-dyn ruby analyzer, as instructed by an abbott representative in association with ticket # (b)(4), a colleague was splashed with the hypochlorite solution she was using.The reporter explained; she was using a syringe with a peristatic tubing as an adapter to clean the flow cell, when the fitting that connects the tubing to the instrument popped off and hypochlorite solution splashed out of the syringe into the room.A colleague was walking by and the hypochlorite splashed onto her forehead, temple and next to her eye.She immediately washed her face.No fluid got into the eye.There was no open skin.There was no treatment required beyond face washing.There was no impact to patient management reported.
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Health effect impact code: f26.Component code: g03001.D8.Was this device serviced by a third party? no.The investigation included review of product historical data and product labeling.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.A review of cell-dyn ruby risk analysis (cd34-sys-104, version 10.4) shows that a hazard, ha561 is related to the incident that was described by the customer.Control measures for ha561 include, instructions in service manual, design of barbed fittings, and instructions in the operator¿s manual to wear personal protective equipment when operating instrument.Based on the investigation, no product deficiency was identified for the complaint issue.
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