PORTEX TUBES BLUSELECT SUCTIONAID

Additional Manufacturer Narrative

ONE USED DECONTAMINATED SAMPLE WAS RETURNED FOR ANALYSIS. FUNCTIONAL AND VISUAL TESTS WERE DONE, BUT THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS LEAKAGE. THIS OCCURRED DURING USE, AND THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

Additional Manufacturer Narrative

B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. 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.