PORTEX TUBES BLUSELECT SUCTIONAID

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED DURING FUNCTIONAL TESTING WHEN THE REPORTED ISSUE WAS DUPLICATED. THE ISSUE WAS TRACED TO A HOLE FOUND IN THE DEVICE CUFF. AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. A ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE OBSERVED HOLE.

Description of Event or Problem

IT WAS REPORTED THAT THE CUFF PRESSURE DID NOT INCREASE. THE REPORTER NOTED THAT REPLACEMENT WAS SCHEDULED FOR ONE MONTH ON 10/21, BUT THE CUFF PRESSURE DID NOT INCREASE ON 11/7, SO IT WAS REPLACED. THEN, ON 11/28, THE CUFF PRESSURE DID NOT INCREASE EITHER, SO IT WAS REPLACED AGAIN. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT PATIENT'S HOME. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

Additional Manufacturer Narrative

H3: 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.