N
Patient 1
THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. THE MANUFACTURING PROCESS WAS REVIEWED AND EACH CUFF IS INFLATED AND INSPECTED FOR VISUAL AND FUNCTIONAL CHARACTERISTICS PRIOR TO PRODUCT RELEASE. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES EACH DEVICE INDICATES: VARIOUS BONY ANATOMICAL STRUCTURES (E.G., TEETH AND TURBINATES) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION TOOLS WITH SHARP SURFACES PRESENT A THREAT TO MAINTAINING CUFF INTEGRITY. TAKE CARE TO AVOID DAMAGING THE THIN-WALLED CUFFS DURING INSERTION, WHICH WOULD CREATE THE NEED TO SUBJECT THE PT TO THE TRAUMA OF EXTUBATION AND RE-INTUBATION. IF CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. INFLATION OF THE CUFF BY "FEEL" ALONE OR BY USING A MEASURED AMOUNT OF AIR IS NOT RECOMMENDED SINCE RESISTANCE IS AN UNRELIABLE GUIDE DURING INFLATION. INTRACUFF PRESSURE SHOULD BE CLOSELY MONITORED WITH A PRESSURE MEASURING DEVICE. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. (B)(4).