PORTEX TUBES BLUSELECT SUCTIONAID

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.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS FOUND CRACKED AFTER 4 DAYS OF INSERTION. THE EVENT OCCURRED DURING USE ON PATIENT.

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.