The reported event is inconclusive because no sample was returned for evaluation and further evaluation was not conclusive.Although a specific cause cannot be determined potential root causes for this event could be, "operator error, improperly flared stopcock leg".The device was attempted to be used for treatment purposes.It is unknown if the device had met relevant specifications or resulted in the reported event.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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