MEDLINE

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, SHE NOTICED DAMAGE TO THE INSIDE OF HER TRACHEOSTOMY TUBE, SHE REPORTS "THE METAL DAMAGED THE INSIDE TRACH AND SPLIT IT APART." ACCORDING TO THE CUSTOMER, OVER TIME THE BRUSH CAUSED THIS TO OCCUR BECAUSE THEY ARE "HARD AND NOT FLEXIBLE." SHE REPORTS DUE TO THIS, SHE WILL NEED TO HAVE THE TUBE REPLACED BY HER DOCTOR. CUSTOMER REPORTS SHE USES THE BRUSHES ONE TIME AND THEN DISPOSES OF THEM. THE SAMPLE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

DAMAGE TO TRACH REQUIRING TUBE TO BE REPLACED.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, SHE NOTICED DAMAGE TO THE INSIDE OF HER TRACHEOSTOMY TUBE, SHE REPORTS "THE METAL DAMAGED THE INSIDE TRACH AND SPLIT IT APART". ACCORDING TO THE CUSTOMER, OVER TIME THE BRUSH HAS CAUSED THIS TO OCCUR BECAUSE THEY ARE "HARD AND NOT FLEXIBLE". SHE REPORTS DUE TO THIS, SHE WILL NEED TO HAVE THE TUBE REPLACED BY HER DOCTOR. CUSTOMER REPORTS SHE USES THE BRUSHES ONE TIME AND THEN DISPOSES OF THEM. A SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.