PORTEX TUBES BLUSELECT SUCTIONAID

Additional Manufacturer Narrative

D9: DATE RETURNED TO MFG.: 6/26/2025. H3 AND H6. CODES: UPDATED. DEVICE EVALUATION: THE SUSPECTED DEVICE WAS RECEIVED IN USED CONDITION. UNDER VISUAL INSPECTION THE SUCTION CONNECTOR SEEMED TO BE WITHOUT ANY DEFECT. WHEN A LUER SLIP SYRINGE WAS INSERTED INTO THE CONNECTOR A CRACK WAS OBSERVED. THE COMPLAINT WAS CONFIRMED. THIS DEFECT CAN BE CAUSED BY APPLYING EXCESSIVE FORCE WHEN CONNECTING THE SYRINGE OR DURING THE CONNECTION OF THE SUCTION DEVICE, THE ROOT CAUSE COULD NOT BE ASSOCIATED WITH THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE INSERTED ON (B)(6) 2025 WAS FOUND TO BE FAULTY. THE TUBE CRACKED WHEN A 10ML SYRINGE WAS INSERTED, AN ISSUE THAT OCCURRED MULTIPLE TIMES RECENTLY. THIS REQUIRED AN URGENT TUBE CHANGE AND THE USE OF DEVICE TO PREVENT INFECTION FOR THE PATIENT. A FAULTY SUBGLOTTIC PORT WAS IDENTIFIED DURING AN OUTPATIENT VISIT, AND THE PATIENT SHOWED INCREASED SECRETIONS AND RISK OF ASPIRATION. A TRACHEOSTOMY TUBE CHANGE WAS CARRIED OUT TO ENSURE SAFE AIRWAY MANAGEMENT. THE ISSUE WAS NOW RESOLVED WITH A NEW TRACHEOSTOMY TUBE.

Additional Manufacturer Narrative

E1 - INITIAL REPORTER PHONE: (B)(6). H3, H6: 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 INFORMATION BECOMES AVAILABLE.