PLEURX PLEURAL CATHETER MINI KIT

Additional Manufacturer Narrative

H11: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. THE COMPLAINT HAS BEEN LOGGED IN THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE MONITORED THROUGH TRACKING, TRENDING, AND QUALITY DATA ANALYSIS FOR POTENTIAL FUTURE OCCURRENCES. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THE PLEURX PLEURAL CATHETER WAS BLOCKED AND THE VALVE HAD BECOME DETACHED. THE SAFETY CLAMP WAS NOT OPEN AT THE TIME OF DISCONNECTION. NO MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO EXPOSURE TO BLOOD OR BODY FLUIDS. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE. THE CATHETER HAD BEEN IN PLACE IN PLEURAL CAVITY SINCE (B)(6) 2026.