No lot number was provided in relation to this complaint; therefore, the device history record could not be reviewed.According to the complaint form, no product is available for return to argon quality in connection with this complaint.Without the return of the product, and with no lot number to review, a definitive cause for the occlusion of the catheter could not be determined.Catheter occlusion can be related to kinks or bends in the catheter under the dressing, conditions in the patient's body, drug and mineral precipitation in the catheter, or the development of thrombus.L-cath catheters are 100% visually inspected at various points in the manufacturing process and 100% leak and flow tested.Control catheters are also tested for tensile strength.
|