BROSELOW

Additional Manufacturer Narrative

(B)(4). CAREFUSION ACQUIRED GE VITAL SIGNS ON (B)(6) 2013. A RETROSPECTIVE REVIEW OF ALL COMPLAINTS POST ACQUISITION WAS PERFORMED. THIS COMPLAINT WAS IDENTIFIED AS BEING MDR REPORTABLE BY CFN STANDARDS AND IS BEING SUBMITTED TO THE FDA. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

THE ET TUBE STYLET IS A TIGHT FIT FOR THE ET TUBE SO THE ET TUBE WAS ACCIDENTALLY PULLED OUT WHILE TRYING TO REMOVE THE STYLET. CUSTOMER HAD TO RE-INTUBATE AND IT TOOK TWO PEOPLE TO REMOVE THE STYLET TO ASSURE THE PATIENT WASN'T EXTUBATED AGAIN. DISCUSSION WITH T. TIMOTHY, TRAUMA PROGRAM COORD. AND VITAL SIGNS CLINICIAN (L. SPITALETTO) ON (B)(6) 2014. THIS WAS AN EMERGENCY CASE, STYLET AND ET TUBE WERE INSPECTED AND PREPARED FOR USE. LUBRICATING JELLY WAS USED IN APPLICATION AS IS THEIR STANDARD PRACTICE. THERE WAS NO DIFFICULTY INSERTING THE STYLET INTO THE TUBE. PATIENT WAS EASILY INTUBATED, VENTILATION WAS FINE. THIS WAS NOT CONSIDERED A DIFFICULT AIRWAY. A GLIDESCOPE WAS NOT UTILIZED. DIFFICULTY WAS EXPERIENCED ON ATTEMPT TO REMOVE STYLET. UPON REMOVAL OF THE STYLET THE PATIENT WAS EXTUBATED. THE PATIENT WAS THE RE-INTUBATED. AFTER SECOND INTUBATION, ONE CLINICIAN HELD THE ET TUBE IN PLACE AS THE OTHER CLINICIAN GENTLY REMOVED THE STYLET. THE FORCE OF HOLDING THE ET TUBE PUSHED THE ET TUBE IN FURTHER THAN ORIGINALLY PLACED REQUIRING A CHEST X-RAY TO FIX/CORRECT ET TUBE PLACEMENT. THERE WAS NO PATIENT INJURY AND NO INTERVENTION REQUIRED BEYOND THESE EVENTS. PATIENT SURVIVED. THE CUSTOMER COMPARED THE OLD BLUE STYLET PREVIOUSLY KITED IN BROSELOW TO THE NEW SILVER STYLET AND NOTES A SLIGHT VISUAL DIFFERENCE IN SIZE (OD). THE BLUE STYLETS WERE ALSO EASIER TO INSERT AND REMOVE AS THEY WERE SMOOTHER (LESS TACKY). THE SILVER STYLET IS MORE DIFFICULT TO REMOVE WHEN BENT INTO POSITION.