MADGIC ATOMIZER WITHOUT SYRINGE

Description of Event or Problem

IT WAS REPORTED THAT: "THE DEVICE TIP FELL OUT INTO A PATIENTS AIRWAY. IT WAS RETRIEVED BY A BRONCOSCOPE. THE PATIENT WAS NOT HARMED."

Additional Manufacturer Narrative

(B)(4) THE CUSTOMER PROVIDED TWO PHOTOS FOR ANALYSIS. THE PHOTOS REVEAL A MAD700 DEVICE WITH THE TIP SEPARATED FROM THE LUMEN AND THE TIP INSIDE THE PATIENT. THE COMPLAINT OF A DETACHED TIP WAS ABLE TO BE CONFIRMED BY THE PHOTOS. THE CUSTOMER RETURNED ONE UNOPENED REPRESENTATIVE SAMPLE MAD700 MADGIC ATOMIZER WITHOUT SYRINGE. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED REPRESENTATIVE DEVICE REVEALED THAT THE SAMPLE APPEARED TYPICAL AND THE TIP WAS ATTACHED TO THE LUMEN. ATTEMPTS TO REMOVE THE TIP WERE MADE USING MODERATE FORCE TO PULL ON THE TIP. THE TIP WOULD NOT SEPARATE FROM THE LUMEN. SINCE THE ACTUAL SAMPLE WAS NOT SENT AND THE REPRESENTATIVE SAMPLE HAD THE TIP ATTACHED, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. ALTHOUGH THE PROBABLE CAUSE COULD NOT BE DETERMINED, NON-CONFORMANCE WAS PREVIOUSLY INITIATED BY THE MANUFACTURING SITE TO FURTHER INVESTIGATE THIS ISSUE. THE ROOT CAUSE WAS IDENTIFIED TO BE A MANUFACTURING ISSUE RELATED TO NO CYCLOHEXANONE BEING APPLIED BETWEEN THE TIP AND THE LUMEN. CORRECTIVE ACTIONS WERE IMPLEMENTED TO HELP PREVENT THIS ISSUE FROM RECURRING. THE SAMPLE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTIONS BEING IMPLEMENTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT OF "DETACHED TIP" WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. VISUAL EXAMINATION OF THE PHOTOS REVEALED THAT THE TIP OF THE DEVICE WAS DISCON-NECTED FROM THE LUMEN TUBE. HOWEVER, FULL COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS THE ACTUAL SAMPLE WAS NOT RECEIVED FOR EVALUATION AND THE RETURNED REPRESENTATIVE SAMPLE HAD THE TIP ATTACHED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. ALTHOUGH PROBABLE CAUSE COULD NOT BE DETERMINED, NON-CONFORMANCE WAS PREVIOUSLY INITIATED AT THE MANUFACTURING SITE TO FURTHER INVESTIGATE THIS ISSUE. THE ROOT CAUSE WAS IDENTIFIED TO BE A MANUFACTURING ISSUE RELATED TO NO CYCLOHEXANONE BEING APPLIED BETWEEN THE TIP AND THE LUMEN. CORRECTIVE ACTIONS WERE IMPLEMENTED TO HELP PREVENT THIS ISSUE FROM RECURRING. THE SAMPLE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTIONS BEING IMPLEMENTED.

Additional Manufacturer Narrative

(B)(4). FAILURE MODE "DETACHED TIP" COULD BE CONFIRMED WITH PICTURE ATTACHED. HOWEVER IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION, DETERMINE THE ROOT CAUSE & CORRECTIVE ACTIONS. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. IF THE COMPLAINT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT: "THE DEVICE TIP FELL OUT INTO A PATIENTS AIRWAY. IT WAS RETRIEVED BY A BRONCOSCOPE. THE PATIENT WAS NOT HARMED."