It was reported that excess force was required to deploy the needle during a lymphadenopathy.The procedure was completed planned.Following the procedure, the user experienced a needle stick as the needle was not retracted into the sheath when it was given to her.It was noted the cause of this is unknown.As a result of the needle puncture, a report was filed in house, the user received a tetanus shot and was tested for hepatitis and hiv along with the patient.They both tested negative.The user is in stable condition.
|
This report is being supplemented to provide additional information (h6, h10) regarding the reported event.The definitive root cause could not be established.Based on the similar issue reported in the past, the probable cause has been determined as resistance increased between the needle tube and the tube which caused the inability of the needle to protrude from the sheath.Per the product instructions for use (ifu): "take the instrument out of the tray by holding the sheath not to make the sheath pop out of the tray.Otherwise, the insertion portion of the instrument might be broken.Also, if the insertion portion pops out of the tray by elasticity, doctors or patients might be injured by the distal end of needle tube, sheath, and stylet.Do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument." device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.
|