No device was returned.The following operations were reviewed, in order to verify that the operations were properly performed, also records were reviewed, in order to ensure that complied with gmp requirements and shm procedures: the 'assemble base with cannula to inserter' operation was reviewed to ensure that the cannula is properly assembled; no discrepancies were found.The operators that perform critical operations such as bond skin adhesive film onto flange of sleeve and the skin adhesive inspections using a monitor are certified.The operator performs the visual inspection of the adhesive using the skin adhesive inspection.4 samples from other lot number were taken from production floor and tested for in-process testing and no discrepancies were found.Visual inspection of 32 samples from a different lot number were taken from production line and were visually inspected in order to verify that the spring is not released.Results: no discrepancies were detected.The retractor assemblies were 100% visually inspected by the production personnel to assure that the needle is properly threaded.Production personnel verified 100% that parts were not damaged (including scratches) or distorted/warped.Quality personnel verifies 100% that the needle tip is up, and the blunt end is fully seated and verify the length while still in the needle hub on the pallet.No root cause could be determined, as no samples or pictures were received for evaluation.No corrective actions are required since the complaint could not be confirmed.A device history record (dhr) review could not be performed, since the lot number was not specified by the customer.It was reported that the patient experienced a reaction at the infusion site, described as edema.No medical or surgical intervention was reported.D5- operator of device patient/consumer this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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