SINGLE SHOT EPIDURAL TRAY

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, DURING A "SINGLE SHOT SPINAL EPIDURAL THE NEEDLE BROKE OFF UNDER A PATIENT'S SKIN". THE CUSTOMER REPORTED THAT AFTER THE REPORTED INCIDENT OCCURRED A "GENERAL SURGEON NEEDED TO MAKE AN INCISION AND REMOVE THE ITEM". THE CUSTOMER REPORTED THE PROCEDURE COMPLETED AND THE PATIENT WAS ABLE TO BE DISCHARGED AFTER THE PROCEDURE. THE CUSTOMER REPORTED THERE WAS NO SERIOUS INJURY OR FOLLOW-UP CARE NEEDED RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, DURING A "SINGLE SHOT SPINAL EPIDURAL THE NEEDLE BROKE OFF UNDER A PATIENT'S SKIN".