CATHETERS SHORT TERM

Additional Manufacturer Narrative

E1: INITIAL REPORTER POSTAL CODE: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED FROM THE "BLUE LUMEN" OF A GAMCATH CATHETER DURING CONTINUOUS VENOVENOUS HEMODIAFILTRATION THERAPY. THE VOLUME OF BLOOD LOSS WAS APPROXIMATELY 100ML. THE CATHETER WAS REPLACED TO CONTINUE TREATMENT, AT WHICH TIME THE RED AND BLUE LUMENS OF THE CATHETER WERE NOTED TO BE "STRONGLY BENT". SOFTASEPT N WAS USED AS A DISINFECTANT WHICH CAME INTO CONTACT WITH THE CATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6, H11. H11: THE DEVICE WAS RECEIVED, AND PHOTOGRAPHS AND A VIDEO OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS AND VIDEO SHOWED BLOOD VISIBLE ON THE VENOUS EXTENSION OF THE DEVICE, AT THE AREA WHERE THE CATHETER HUB CONNECTS TO THE FLEXIBLE EXTENSION TUBING. INSPECTION OF THE ACTUAL SAMPLE WITH THE NAKED EYE SHOWED A DAMAGED SURFACE FROM THE CATHETER EXTENSION. A SMALL HOLE WITH AN APPROXIMATE LENGTH OF 3-4MM WAS VISIBLE NEAR THE HUB BORDERLINE. FUNCTIONAL LEAK TESTING WAS PERFORMED ON THE VENOUS LUMEN, AND A LEAK WAS CONFIRMED. THE CUSTOMER REPORTED THAT THE DEVICE LUMENS WERE BENT, INDICATING THAT THE CONNECTIONS WERE USED IN STRAIGHT FORM DURING THERAPY, VERSUS THE J FORM INTENDED. THIS USE CAUSED EXTRA FORCE AND TENSION ON THE COMPONENTS. ADDITIONALLY, AN ALCOHOLIC BASED DISINFECTION SOLUTION WAS USED DURING TREATMENT, WHICH WAS INCOMPATIBLE WITH THE MATERIAL OF THE CATHETER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE DEVICE DAMAGE WAS DETERMINED TO BE RELATED TO UNINTENDED USE OF THE PRODUCT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.