DISP FIRSTPASS STR PASSR SELF

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING A PROCEDURE, THE TIP OF ONE (1) FIRSTPASS OPENED IN THE WRONG DIRECTION. THE NURSE PRICKED HERSELF AND WAS ACCIDENTALLY EXPOSED TO BLOOD. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.