Additional information provided in b.5., d.9., h.3., h.6., and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria the returned sample was visually inspected.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.The silicone tubing with the infusion cannula tip detached from the straight though connector in the returned condition.Indentation mark on the tubing appeared that the tubing was once attached to the straight though connector.The diameter of the fitting was flat in an oval shape.A calibrated console representing the current software version was used to test the sample.The ball in the drip chamber¿s check valve moved freely per specification.The light emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The sample could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The misshape on the fitting diameter did not prevent the fluid from flowing.The supplier investigated retained samples and production records from the supplier lot in question and inspection did not indicate any anomalies occurred during the manufacturing of the suspect lot.If any equipment were to cause this type of damage, a fault report would have been filed and more product would have been noted as damaged.Review of maintenance records did not reveal any issues with production or packaging equipment.No additional complaints have been reported.Upon microscopic examination of the returned sample, one of the barbs is severely compressed and 25% of the barb edge is damaged.Deep striation on the damaged barb tip, along with severe compression, indicates excessive external forces were applied.Drag marks indicate metal or hard plastic peeled over the barb edge and extended to the barb tip.After an analysis and based on the condition of the sample, the root cause is potentially related to an error during the suppliers assembly process.The supplier performed a root cause evaluation and determined the damage was caused by external factors not part of their manufacturing process.After an investigation of this complaint, it has determined that no further actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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