PORTEX TUBES BLUSELECT SUCTIONAID

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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT THE SUCTION AIDE TUBE WAS INSERTED IN THEATER. THE TUBE HAD REMAINED IN PLACE THE (B)(6) 2025 UNTIL (B)(6) 2025. THE SUCTION PORT WAS CRACKED AND UNABLE TO BE USED. THE EVENT OCCURRED DURING USE ON PATIENT.

Additional Manufacturer Narrative

H6: CODES WERE UPDATED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT VISUAL INSPECTION SUCTION OF CONNECTOR, NO PHYSICAL DAMAGE OR OTHER ANOMALIES OBSERVED. WHEN ACCESSED WITH A LUER SLIP SYRINGE, A CRACK WAS OBSERVED. THE COMPLAINT OF SUCTION PORT BEING CRACKED CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE CRACK IS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.