PORTEX TUBES BLUSELECT SUCTIONAID

Additional Manufacturer Narrative

A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THERE HAVE BEEN PROBLEMS WITH CUFF LEAKAGE. IT SEEMS TO BE AN ISSUE WITH THE VALVES TO THE CUFF TUBE. WHEN THE CUFF PRESSURE GAUGE IS CONNECTED IT SEEMS TO WORK, BUT WHEN DISCONNECTED, A LEAKAGE OCCURS. THE CUFFS THEMSELVES DO NOT SEEM DEFECTIVE. THERE HAVE BEEN SEVERAL PATIENTS WHO HAD TO BE CHANGED FREQUENTLY DUE TO THIS REASON. THE CANNULAS THAT WERE REPLACED EARLIER HAVE BEEN RETAINED AND CUFFED OVERNIGHT WITHOUT ANY LEAKAGE. THEY LOSE 5-10 CM H2O WHEN CONNECTED TO THE CUFF PRESSURE GAUGE, BUT IT SEEMS TO BE A KNOWN ISSUE. IN SOME CASES, THE WARD STUFF, KEPT THE CUFF PRESSURE GAUGE CONNECTED CONSTANTLY. IT IS BELIEVED THAT THIS CONCERNS OPERATIONAL ERRORS. PHOTO OF THE SAMPLE HAS BEEN PROVIDED. THERE WAS PATIENT INVOLVEMENT. ASSOCIATED COMPLAINT DOCUMENTED (B)(4).

Additional Manufacturer Narrative

D1 - BRAND NAME, D2A - COMMON DEVICE NAME, D2B - PROCODE, D4 - EXPIRATION DATE, D4 - PRIMARY UDI NUMBER, H4 - DEVICE MFG DATE, AND H5 - LABELED FOR SINGLE USE: CORRECTION D9: DATE RETURNED TO MFG.: 6/30/2025 H3 AND H6. CODES: UPDATED. DEVICE EVALUATION: THE SUSPECTED DEVICE WAS RECEIVED IN USED CONDITION IN A PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION THE DEVICE APPEARED TO BE IN GOOD CONDITION. DURING THE MANUFACTURING PROCESS THE DEVICES ARE 100% INFLATION TESTED WHICH INCLUDES INFLATING EACH DEVICE CUFF AND LEAVING FOR A 12-HOUR PERIOD. REDUCTIONS IN PRESSURE OVER THIS TIME ARE CONSIDERED A FAILURE AND THE DEVICE WOULD BE REJECTED. THE INFLATION TEST WAS REPEATED ON THE DEVICE RECEIVED. IT WAS CONFIRMED THAT AFTER 12 HOURS THE CUFF WAS STILL FULLY INFLATED. THE COMPLAINT COULD NOT BE CONFIRMED/REPLICATED. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED ONE COMPLAINT WAS RECEIVED AGAINST THE REPORTED LOT NUMBER DESCRIBING A DIFFERENT ISSUE AND HAS BEEN CONFIRMED.