Description of Event or Problem · 1
ON MARCH 22, 1992, A PHYSICIAN ASSISTANT (P.A.) WAS REMOVING A CHEST TUBE PER PHYSICIAN'S ORDER. A SUTURE HOLDING THE CHEST TUBE IN PLACE WAS CLIPPED. THE CHEST TUBE WAS REMOVED WITHOUT DIFFICULTY. UPON EXAMINATION, THE PHYSICIAN ASSISTANT OBSERVED THAT THE CHEST TUBE WAS APPARENTLY IN TWO PIECES WITH APPROXIMATELY SIX INCHES OF CHEST TUBE REMAINING IN THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY AND THE RETAINED PORTION OF THE CHEST TUBE WAS REMOVED UNDER LOCAL ANESTHESIA WITH FLUROSCOPY AND WITHOUT THE NEED FOR AN INCISION. THERE WAS NO SIGNS OR SYMPTOMS OF INFECTION AT THE SITE. THE PATIENT EXPERIENCED NO RESPIRATORY COMPROMISEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MODIFICATION OF DEVICE - BY USER, FAILURE TO FOLLOW INSTRUCTIONS. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.