PORTEX TUBES BLUSELECT SUCTIONAID

Description of Event or Problem

IT WAS REPORTED THAT THE TUBE CRACKED ABOVE THE CUFF SUCTIONAID AND WAS NOT ABLE TO SUCTION THE PATIENT. THERE WAS A TRACHEOSTOMY CHANGE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

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.

Additional Manufacturer Narrative

D9: 08-JUL-2025. H3: ONE DEVICE WAS RECEIVED FOR EVALUATION IN USED CONDITION. FOUR PICTURES WERE RETURNED SHOWING COMPLAINT FORMS AND THE SAMPLE IN BIOHAZARD BAG. AS RECEIVED, THE SUCTION LINE LUER WAS OBSERVED TO BE WRAPPED IN TAPE. UPON REMOVAL OF THE TAPE, NO DAMAGE OR ANOMALIES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, AND A SINGULAR CRACK WAS FOUND ON THE LUER. THE COMPLAINT OF SUCTION PORT BEING CRACKED CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE CRACK IS UNKNOWN. A LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.