HOBBS MEDICAL MICROBIOLOGY BRUSH

Additional Manufacturer Narrative

DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND WAS DISCARDED BY THE HEALTHCARE FACILITY. THE DEVICE IS INTENDED FOR USE IN THE GASTROINTESTINAL TRACT, NOT IN THE LUNGS. USE IN THE LUNGS IS THEREFORE CONSIDERED OFF-LABEL USE. MISBRANDED PRODUCTS WITHIN THIS PRODUCT FAMILY LABELED AS "BRONCHIAL" WERE RECALLED BY HOBBS MEDICAL IN 2021 (REF Z-0711-2022), AND AFFECTED CONSIGNEES NOTIFIED. CONFIRMED THAT THE DEVICE LOT INVOLVED IN THIS COMPLAINT WAS PROPERLY LABELED FOR GASTROINTESTINAL USE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION ON THE PATIENT'S CONDITION IS RECEIVED.

Description of Event or Problem

IT WAS REPORTED THAT THE DISTAL ATRAUMATIC BALL TIP OF THE MICROBIOLOGY BRUSH FELL OFF WHICH THE DEVICE WAS IN THE PATIENT'S RIGHT UPPER LOBE OF THE LUNG. ACCORDING TO THE PHYSICIAN, THEY NOTICED THE TIP HAD FALLEN OFF WHILE INSIDE THE LUNG AND WHEN THE DEVICE WAS RETRACTED FROM THE SCOPE, THERE WAS NO TIP ON THE DEVICE. PHYSICIAN CONFIRMED THE TIP WAS NOT LODGED IN THE SCOPE AND DID NOT FEEL IT WOULD BE POSSIBLE TO SUCTION THE SEPARATED COMPONENT OUT OF THE LUNG. PHYSICIAN PLANNED TO SEND THE PATIENT FOR SCANS TO IDENTIFY THE LOCATION OF THE TIP IN THE LUNG.