Description of Event or Problem · 0
PROBLEM AS REPORTED ON MEDWATCH REPORT (B)(4). PRIOR TO OUR CASE, WE TESTED MULTIPLE ANESTHESIA LASER TUBES, AND THEY WERE NOT WORKING PROPERLY, THE DISTAL NOT INFLATING ON ONE AND THE PROXIMAL NOT INFLATING ON THE OTHER, THE CUFF WAS NOT INFLATING PROPERLY. WE DID FURTHER DIVE AND NOTICED THE LOT NUMBER ON THE BOX IS NOT THE SAME AS THE LOT ON THE ACTUAL PACKAGE, THIS IS REGARDING THE TENAX LASER RESISTANT ENDOTRACHEAL TUBE KIT. HOWEVER, ONE OF THE TUBES DID WORK BUT IT STILL HAD THE SAME LOT NUMBER AS THE ONES NOT WORKING. WHILE THE INCIDENT OCCURED IN OCT 2023, IS WAS NOT REPORTED TO BRYAN MEDICAL UNTIL JUL 2024. AT THIS TIME THE TWO DEVICES WERE RETURNED FOR INVESTIGATION. IT WAS FOUND THAT DEVICE 1 INFLATED CORRECTLY AFTER FOLLOWING INSTRUCTIONS INCLUDED IN THE GUIDE TO APPROPRIATE USE. DEVICE 1 PERFORM AS INTENDED, CONCLUDING THAT A NONCONFORMANCE IS NOT VALID. DEVICE 2 WOULD NOT INFLATE, EVEN AFTER FOLLOWING THE GUIDE TO APPROPRIATE USE. IT WAS NOTED THAT THE DEVICE WAS RETAINED BY THE HOSPITAL FOR APPROXIMATELY 9 MONTHS AND THE PILOT BALLON STILL CONTAINED FLUID UPON RECEIPT. THE CELLULOSE STRIP THAT CONTAINS THE BLUE DYE HAD COMPLETELY BROKEN DOWN AND WAS FLOATING AROUND WITHIN THE PILOT BALLOON AND INFLATION LINES IN MANY SMALL PIECES. THIS WAS VISIBLY OCCLUDING THE INFLATION LINES. GIVEN THAT THE CELLULOSE STRIP HAD BEEN IN CONTACT WITH FLUID FOR APPROXIMATELY 9 MONTHS BEFORE BEING RETURNED FOR EVALUATION, VALIDITY OF THE COMPLAINT AND ROOT CAUSE FOR FAILURE OF THE CUFF INFLATE COULD NOT BE DETERMINED. ADDITIONALLY, THE TENAX LASER RESISTANT TUBE COMES IN A CONVENINCE KIT CONSISTING OF TWO PRODUCTS PACKAGED TOGETHER. ONCE THE ITEMS ARE KITTED A LOT NUMBER IS ISSUED FOR THE KIT WHICH WOULD NOT BE THE SAME AS THE LOT NUMBER FOR THE INDIVIDUAL DEVICE.