The documentation shows a probable causal relationship between the event of the patient ¿recapping without the pin¿ during ccpd therapy; representing a possible breach in aseptic technique and possibly leading to the development of abdominal pain, and peritonitis which lead to hospitalization and the incident of exacerbation of the patients¿ hernia.However, the association of the adverse event and the ¿pin¿ not setting into the catheter correctly as a possible contributor cannot be ruled out.The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.
|