PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAY

Additional Manufacturer Narrative

THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO THE MFR TO EVALUATE. WITHOUT THE SAMPLE A THOROUGH EVAL COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IT SHOULD BE NOTED, THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS PRODUCT INDICATE "CAUTION: DO NOT WITHDRAW CATHETER THROUGH NEEDLE DUE TO POSSIBLE DANGER OF SHEARING."

Description of Event or Problem

AS REPORTED BY THE SALES REP PER THE USER FACILITY. THE TIP OF THE CATHETER BROKE OFF WHEN REMOVED. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE PT SUFFERED NO ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. THE CATHETER TIP WAS NOT LOCATED ON X-RAY AND IT IS UNCERTAIN IF THE CATHETER TIP REMAINS IN THE PT OR IF IT WAS LOST DURING REMOVAL.