The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Unique device identification (udi): (b)(4).Failure analysis - the complaint device was retuned with the valve (mfg report number 3013886523-2021-00402).The position of the cam when valve was received was at setting 2.The valve was visually inspected; needle holes in the needle chamber were noted and marks in the proximal connector were also noted.The valve was hydrate.The catheter was irrigated, no occlusions noted.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the catheter, at the time of investigation the no occlusion issues were noted with the catheter.
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