Internal complaint # (b)(4).Autonumber # (b)(4).Added device code [2991] no flow.The certificate of conformance was reviewed.The vendors conform that the device lot conforms to all applicable product specifications.There were no non-conformities observed.The device was returned to the factory for evaluation.A visual inspection was conducted.No signs of clinical use and no evidence of blood was observed.The device was returned inside the sealed packaging.No tears or rips were observed on the package.The device was observed in the package intact, no visual defects were observed.The package was opened and the product was investigated.A mechanical evaluation was conducted.Following the instructions in ifu ((b)(4), instruction for use), the braided (0.64cm) tube was connected to the regulated source of c02 set with not more than 35 psi.The flow control for the saline was adjusted to 5 l/min (0.08 l/s).Care was taken that it doesn't exceed 8 l/min.The pinch clamp on iv tubing was closed and the iv spike was connected to a new bag of sterile saline with pressure cuff around it.After opening the pinch clamp, the sterile saline flowed through the tube.It was observed that there was no co2 flow through the atraumatic tip of the blower mister.The flow volume controller on the hand piece was manipulated forward and backward but it was observed that there was still no flow of co2.No audible sound of the c02 gas was heard at the atraumatic tip.Further inspection was conducted.The hand piece was opened.To determine patency of the tubes, a blue dyed saline fluid was injected into the saline port.There were no blockages and the fluid flowed through all the way to the tip and out it dripped.The same test was conducted on the co2 tube.The fluid did not flow through the tube and resistance was felt when the fluid was pushed into the co2 tube.The resistance indicated blockage in the co2 tube.On microscopic inspection, it was observed that there was obstruction caused by the uv glue at the connection site of the co2 gas tube and the coupler.There were signs of glue migration, resulting in the obstruction and blockage of the co2 air flow track.Based on the returned condition of the device and the investigation results, the reported failure ¿no apparent adverse event" was not confirmed but was confirmed for the reported failure ¿no flow ".Field action plan was implemented and shipping hold has been implemented for affected lot numbers.The field action form is attached to the complaint for review.Specific actions for the reported confirmed failure mode are being maintained and documented under maquet's health hazard evaluation (hhe) system.
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