THORA-SEAL

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER STATED THE RESPIRATORY WARD MANAGER REPORTED AN INCIDENT WITH PRODUCT 8884713308. HISTORICALLY, THIS ITEM HAS BEEN PROCURED FOR USE WITHIN THE ICU AND STAFF IN THE RESPIRATORY DEPARTMENT ARE NOT FAMILIAR WITH THIS PRODUCT, PARTICULARLY REGARDING ITS ASSEMBLY AND CONNECTION. THIS HAS RESULTED IN DIFFICULTIES DURING PATIENT CARE FOLLOWING THE INSERTION OF A THORACIC DRAIN. IN THE FIRST INCIDENT, THE WARD 17 ACP WAS CALLED UP TO THEATRES TO PROVIDE ADVICE AND SUPPORT ON USING AND FILLING THE BOTTLE. THERE WAS NO HARM TO THE PATIENT AND INSTRUCTION WERE GIVEN TO THE STAFF. IN THE SECOND INCIDENT, THE PATIENT ALREADY HAD A CHEST DRAIN IN PLACE THAT NEEDED REPLACING - THE PATIENT WENT TO THE THEATRE ON FRIDAY (B)(6) AT AROUND 20.00 HOURS. HE RETURNED AND WAS STABLE. ON THE (B)(6) 2026, MEDICS NOTICED THAT THE DRAIN WAS NOT ON SUCTION AND THE NURSE ON WARD 17 APPLIED SUCTION. IT WAS NOTED ON THE EVENING OF THE (B)(6) 2026 THAT THE PATIENTS SURGICAL EMPHYSEMA HAD ADVANCED AND MEDICS WERE CALLED. THERE WAS STILL NO RECOGNITION FROM DOCTORS OR NURSES THAT THE WATER CHAMBER WAS EMPTY. ON MONDAY (B)(6), THE ACP RECOGNIZED THIS, AS SHE IS FAMILIAR WITH THE DRAIN AND WATER WAS APPLIED. THE CUSTOMER ASKED FOR GUIDANCE AND TRAINING FOR CLINICAL STAFF ON THE CORRECT USE AND ASSEMBLY OF THIS PRODUCT. THE CARDINAL REP CONTACTED THE CUSTOMER SEEKING CLARIFICATION. THEY CONFIRMED THAT THE ISSUE WAS DUE TO USER ERROR. THE CARDINAL REP LOOPED IN CLINICAL AFFAIRS TO SUPPORT AS WELL. AN IFU REFERENCE AND TRAINING MATERIALS WERE SENT TO THE CUSTOMER. ADDITIONAL HANDS-ON TRAINING WAS OFFERED BUT WAS NOT ACCEPTED. THE DEVICE HAS BEEN DISCONTINUED FROM THE UK MARKET AS OF (B)(6). IT IS POSSIBLE THAT THE SITE AND DISTRIBUTION CENTERS ARE STILL WORKING THROUGH STOCK. THE REP ASKED THE CUSTOMER TO STOP USING THE DEVICE UNLESS THE STAFF HAS BEEN PREVIOUSLY TRAINED BY CARDINAL HEALTH OR A PEER-TO-PEER TRAINING.