PORTEX BLUSELECT SUCTIONAID TRACHEOSTOMY TUBE

Description of Event or Problem

IT WAS REPORTED THAT THE OPERATOR WENT TO CHECK ON THE PATIENT BECAUSE THE LOW-PRESSURE ALARM ON THE RESPIRATOR WAS SOUNDING AND FOUND THAT THE CUFF TIP HAD COME OFF. THE OPERATOR REPLACED THE TUBE ON THE SPOT. THE EVENT OCCURRED AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE LOT/SERIAL INFORMATION IS UNKNOWN. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED DURING VISUAL INSPECTION, WHICH VERIFIED THAT THE DEVICE PILOT BALLOON WAS DETACHED. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED.