D
Patient 1
PRESENTED TO ER FOR CHEST PAIN AND SOB AFTER LIFTING WEIGHTS. CXR SHOWED LARGE LEFT-SIDED PNEUMONIA. CHEST TUBE REPLACED. POST CXR SHOWED RE-EXPANSION OF THE LEFT LUNG. EARLY FOLLOWING AM (B)(6) 2019, LARGE CONSTANT AIR LEAK NOTED FROM CHEST TUBE. WAS DISCOVERED THE TUBING FROM THE SUCTION HAD BECOME DISCONNECTED (FOUND THE SUCTION HAD BEEN CONNECTED TO AN INTERNAL STIFFENER STYLET INSIDE THE CHEST TUBE WHICH HAS SLID OUT LEAVING THE CIRCUIT DISCONNECTED AND CHEST TUBE AT LEFT CHEST WALL TO AIR). THE STIFFENER STYLET WAS DISCARDED AND THE SUCTION WAS REATTACHED DECREASING THE AIR LEAK. CXR SHOWED RIGHT HAND INTERVAL INCREASE IN SMALL LEFT APICAL PNEUMOTHORAX. CONTINUE WITH PERSISTENT AIR LEAK DUE TO FAILURE OF NON OPERATIVE TX. ON (B)(6) 2019 TO SURGERY FOR BILATERAL VATS, BLEB RESECTION, PLEURECTOMY, AND PLEURODESIS. ONGOING TREATMENT. REPORTING CONCERN REGARDING THE DESIGN OF THE CHEST TUBE THAT ALLOWS THE TROCAR / STYLET TO BE FORCED INTO THE CHEST TUBE WHICH ALLOWS THE TROCAR / STYLET TO BE ABLE TO BE SCREWED TO / LEUR LOCKED ONTO THE CHEST TUBE ITSELF LEAVING OPEN RISK FOR ERROR WHEN INSERTING TO BE THE CHEST TUBE LEADING TO LARGE LEAKS AND INEFFECTIVENESS / MALFUNCTION OF THE CHEST TUBE, IF THE TROCAR / STYLET WAS ATTACHED AND LEFT IN THE CHEST TUBE IN ERROR IN THE PROCESS OF INSERTION. FDA SAFETY REPORT ID# (B)(4).