Cook spectrum minocycline/rifampin impregnated double lumen central venous catheter set.Investigation ¿ evaluation: a review of the drawing, documentation, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.There is no definitive evidence that the device was not manufactured to current manufacturing specifications.The user admits that they were testing the wire prior to patient contact.Per the quality engineering risk assessment no further action is required.
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