The lot number for the device was not provided, a lot history review was not performed.The sample was not returned to the manufacturer for evaluation.The investigation was inconclusive for reported difficult to remove, tilt and perforation.Based upon the available information, the definitive root cause is unknown.The device was labeled for single use.
|
This report summarizes one malfunction.A review of the reported information indicated that the unknown model g2x filter allegedly reported difficult to remove, tilt and perforation.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient's age, sex and weight were unknown.
|