PORTEX EPIDURAL CATHETER LATERAL EYES CLEAR

Additional Manufacturer Narrative

H3: NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT OF FAILURE OF A TRACHEOSTOMY BALLOON COULD NOT BE CONFIRMED BY INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE OF EPIDURAL CATHETER INSERTION USING THE DOGLIOTTI TECHNIQUE AT L3-L4 WITH A 16G TUOHY NEEDLE AND 16G CATHETER; THE EPIDURAL SPACE WAS IDENTIFIED AND PREVIOUSLY TESTED WITH A 3 ML DOSE OF 1% LIDOCAINE "C SLASH V". THERE WAS A TECHNICAL COMPLICATION WITH ABNORMAL RESISTANCE DURING THE CATHETER INSERTION, FOLLOWED BY ITS RUPTURE. AFTER REMOVING THE REMAINING PART OF THE DEVICE, IT WAS NOTED THAT THE CATHETER HAD RUPTURED, WITH AN ESTIMATED 4 CM OF THE EPIDURAL CATHETER LIKELY REMAINING IN THE EPIDURAL SPACE, VISUALLY ESTIMATED BY THE ABSENT SEGMENT. THE DISTRIBUTOR OF THIS PRODUCT IS CIRURGICA FERNANDES, AND AS PER REPORT THIS EVENT WAS NOT NOTIFIED TO THEM. THE TYPE OF PROCEDURE WAS CHILDBIRTH. THERE WERE PATIENT INVOLVEMENT AND INJURY REPORTED. AS A MEASURE ACTION TAKEN AFTER THE PROBLEM WAS IDENTIFIED, THE PATIENT WAS KEPT UNDER OBSERVATION AFTER THE INJURY. THIS COMPLAINT WAS REPORTED TO THE REGULATORY AGENCY ANVISA REFERENCE NUMBER IS (B)(4).

Additional Manufacturer Narrative

H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

NO DEVICE WAS RECEIVED FOR INVESTIGATION. THEREFORE, THE REPORTED COMPLAINT IS UNABLE TO BE CONFIRMED. IF THE DEVICE IS RECEIVED, THE INVESTIGATION WILL BE RE-OPENED FOR FURTHER EVALUATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF THIS PRODUCT.