BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE
Report
- Report Number
- 1018233-2016-01736
- Event Type
- Death
- Date Received
- December 1, 2016
- Report Date
- January 10, 2017
- Manufacturer
- C.R. BARD, INC. (MONCKS) -1030583
- Product Code
- KNT
- PMA / PMN Number
- PREAMENDMENT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THREE POSSIBLE LOT NUMBERS WERE IDENTIFIED IN THE FACILITIES SALES HISTORY; HOWEVER, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "EQUIPMENT NEEDED: A TUBE FOR CONTROL OF BLEEDING ESOPHAGEAL VARICES WITH BALLOONS ATTACHED; MERCURY MANOMETER OR ANEROID GAUGE TYPE OF SPHYGMOMANOMETER TO BE CONNECTED WITH A ¿Y¿ GLASS TUBE TO UPPER SAUSAGE BALLOON; 50CC SYRINGE; CONSTANT INTESTINAL SUCTION MACHINE; WATER SOLUBLE LUBRICATING JELLY (NOT PETROLEUM JELLY); GLASS OF WATER WITH STRAW; THREE RUBBER SHOD CLAMPS (CRILE, KELLY OR KOCHER); 2-1/2 FEET HIGH GRADE RUBBER TUBING (SIZE AND QUALITY USED ON BLOOD PRESSURE MANOMETER). INSTRUCTIONS FOR PASSING THE TUBE: TEST BALLOONS FOR AIR LEAKS AND COAT THE LOWER PARTS OF THE TUBE AND BOTH BALLOONS WITH A THIN COAT OF LUBRICATING JELLY; EVACUATE ALL THE AIR FROM THE GASTRIC AND ESOPHAGEAL BALLOONS AND REINSERT THE RUBBER PLUGS; AFTER SPRAYING THE NOSTRILS WITH A TOPICAL ANESTHETIC, PASS THE TUBE THROUGH THE NOSTRIL UNTIL THE TIP IS IN THE POSTERIOR PHARYNX OR THROAT. AS THE PATIENT SWALLOWS WATER, PASS THE TUBE TO AT LEAST THE 50CM MARK SO THAT THE TUBE NUMBERS MARKED ON THE TUBING WILL BE ALONG THE RIGHT LATERAL ASPECT OF THE ESOPHAGUS. PROPER PLACEMENT MAY BE VERIFIED BY X-RAY. INFLATE THE GASTRIC BALLOON WITH 200CC TO 250CC OF AIR, CLAMP CONICAL PORTION OF THE GASTRIC BALLOON INFLATION TUBE APPROXIMATELY 3CM FROM THE END (AVOID THE SMALL TUBULAR PORTION OF THE GASTRIC BALLOON), AND PULL BACK ON THE TUBE UNTIL RESISTANCE IS ENCOUNTERED. (THE GASTRIC BALLOON IS SO CONSTRUCTED THAT WITH THE NUMBERS ON THE TUBE IN THE RIGHT LATERAL POSITION, THE CARDIA AND FUNDUS OF THE STOMACH WILL BE ENGAGED.) AFTER THE GASTRIC BALLOON HAS BEEN ENGAGED, WITH A MINIMUM OF TENSION ON THE TUBE, FIX THE UPPER END OF THE TUBE AS IT EMERGES FROM THE NOSTRIL BY A CUFF OF SPONGE RUBBER HELD IN PLACE BY AN ADHESIVE TAPE BAND. FINALLY, INFLATE THE ESOPHAGEAL BALLOON TO 35-40MM OF MERCURY PRESSURE; NEXT, ASPIRATE THROUGH THE STOMACH TUBE ALL AIR, WATER AND BLOOD. IT IS NECESSARY DURING THIS STEP TO IRRIGATE THE TUBE AND STOMACH CONTINUOUSLY WITH 50CC OF WATER TO PREVENT CLOTTED BLOOD FROM PLUGGING THE TUBE. CAUTION: IT IS MOST IMPORTANT THAT THE STOMACH BE CLEARED OF BLOOD PROMPTLY SINCE SUBSEQUENT SAMPLING WILL BE A TRUE INDEX OF THE EFFECTIVENESS OF HEMORRHAGE CONTROL FROM THE VARICES IN THE ESOPHAGEAL WALL; IF, AFTER CAREFUL LAVAGING OF THE STOMACH FOR 30 MINUTES BRIGHT RED BLEEDING CONTINUES, INCREASE THE ESOPHAGEAL BALLOON PRESSURE TO 45MM OF PRESSURE. AT THE SAME TIME, CONTINUE TO WASH THE STOMACH WITH WATER SO THAT THE MOMENT BLEEDING IS CONTROLLED, IT WILL BE DETECTED. UNDER NORMAL CIRCUMSTANCES ESOPHAGEAL BALLOON PRESSURE SHOULD NOT EXCEED 45MM OF MERCURY, AND IT IS NOT UNCOMMON FOR A PATIENT TO COMPLAIN OF SUBSTERNAL PRESSURE AS THE HIGHER PRESSURES IN THE BALLOON ARE REACHED, PARTICULARLY IF THEY ARE REACHED TOO RAPIDLY. WHEN THE BALLOON IS IN THE PROPER POSITION, THE PRESSURE WILL VARY WITH RESPIRATORY MOVEMENTS AND ESOPHAGEAL CONTRACTIONS. OCCASIONALLY THESE VARIATIONS WILL CAUSE THE BALLOON PRESSURE TO RISE TO 70MM OF MERCURY. THE BASE LINE PRESSURE IS THE ONE OF IMPORTANCE, AND NOT THE TRANSIENT PEAK PRESSURES; IF ESOPHAGEAL BALLOON PRESSURE IS MAINTAINED AT 45MM OF MERCURY AND BLEEDING CONTINUES, IT IS SUGGESTIVE OF A GASTRIC WALL VARIX. IN THIS CASE, THE PATIENT IS GIVEN ADDITIONAL SEDATION IF NECESSARY AND THE TUBE IS SNUGGED UP ON THE NOSE FIRMLY AND TAPED SECURELY. FINALLY, THE GASTRIC BALLOON IS INFLATED WITH MORE AIR GRADUALLY UP TO A TOTAL OF 300-400CC OF AIR. WARNING: THIS DEGREE OF PRESSURE CAUSES ULCERATION OF THE MUCOSA WITHIN A FEW HOURS; THEREFORE, PATIENT MUST BE PREPARED FOR SUTURE OF THE GASTRIC VARICES AS SOON AS THE GENERAL CONDITION PERMITS; AFTER THE MINIMAL PRESSURE IN THE ESOPHAGEAL BALLOON HAS BEEN DETERMINED BY EVIDENCE OF CONTROL OF BLEEDING, CLAMP THE TUBING AS INDICATED IN THE DIAGRAM TO PREVENT AIR LEAKS. DESPITE THIS PRECAUTION, FREQUENT PRESSURE CHECKS SHOULD BE MADE (EVERY 30-60 MINUTES) TO GUARD AGAINST ANY UNDETECTED AIR LEAKS IN THE SYSTEM; AFTER THE STOMACH HAS BEEN COMPLETELY EVACUATED OF BLOOD, CONNECT THE STOMACH ASPIRATION TUBE TO CONSTANT SUCTION DURING THE FIRST 12 HOURS ONLY. IRRIGATE AND ASPIRATE THE TUBE EVERY 30 MINUTES WITH 50CC OF WARM WATER, AND RECORD COLOR OF ASPIRATED FLUID." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "EQUIPMENT NEEDED: A TUBE FOR CONTROL OF BLEEDING ESOPHAGEAL VARICES WITH BALLOONS ATTACHED. MERCURY MANOMETER OR ANEROID GAUGE TYPE OF SPHYGMOMANOMETER TO BE CONNECTED WITH A ¿Y¿ GLASS TUBE TO UPPER SAUSAGE BALLOON. A 50CC SYRINGE. CONSTANT INTESTINAL SUCTION MACHINE. WATER SOLUBLE LUBRICATING JELLY (NOT PETROLEUM JELLY). GLASS OF WATER WITH STRAW. THREE RUBBER SHOD CLAMPS (CRILE, KELLY OR KOCHER). A 2-1/2 FEET HIGH GRADE RUBBER TUBING (SIZE AND QUALITY USED ON BLOOD PRESSURE MANOMETER). INSTRUCTIONS FOR PASSING THE TUBE: TEST BALLOONS FOR AIR LEAKS AND COAT THE LOWER PARTS OF THE TUBE AND BOTH BALLOONS WITH A THIN COAT OF LUBRICATING JELLY. EVACUATE ALL THE AIR FROM THE GASTRIC AND ESOPHAGEAL BALLOONS AND REINSERT THE RUBBER PLUGS. AFTER SPRAYING THE NOSTRILS WITH A TOPICAL ANESTHETIC, PASS THE TUBE THROUGH THE NOSTRIL UNTIL THE TIP IS IN THE POSTERIOR PHARYNX OR THROAT. AS THE PATIENT SWALLOWS WATER, PASS THE TUBE TO AT LEAST THE 50CM MARK SO THAT THE TUBE NUMBERS MARKED ON THE TUBING WILL BE ALONG THE RIGHT LATERAL ASPECT OF THE ESOPHAGUS. PROPER PLACEMENT MAY BE VERIFIED BY X-RAY. INFLATE THE GASTRIC BALLOON WITH 200CC TO 250CC OF AIR, CLAMP CONICAL PORTION OF THE GASTRIC BALLOON INFLATION TUBE APPROXIMATELY 3CM FROM THE END (AVOID THE SMALL TUBULAR PORTION OF THE GASTRIC BALLOON), AND PULL BACK ON THE TUBE UNTIL RESISTANCE IS ENCOUNTERED. (THE GASTRIC BALLOON IS SO CONSTRUCTED THAT WITH THE NUMBERS ON THE TUBE IN THE RIGHT LATERAL POSITION, THE CARDIA AND FUNDUS OF THE STOMACH WILL BE ENGAGED.) AFTER THE GASTRIC BALLOON HAS BEEN ENGAGED, WITH A MINIMUM OF TENSION ON THE TUBE, FIX THE UPPER END OF THE TUBE AS IT EMERGES FROM THE NOSTRIL BY A CUFF OF SPONGE RUBBER HELD IN PLACE BY AN ADHESIVE TAPE BAND. FINALLY, INFLATE THE ESOPHAGEAL BALLOON TO 35-40MM OF MERCURY PRESSURE. NEXT, ASPIRATE THROUGH THE STOMACH TUBE ALL AIR, WATER AND BLOOD. IT IS NECESSARY DURING THIS STEP TO IRRIGATE THE TUBE AND STOMACH CONTINUOUSLY WITH 50CC OF WATER TO PREVENT CLOTTED BLOOD FROM PLUGGING THE TUBE. CAUTION: IT IS MOST IMPORTANT THAT THE STOMACH BE CLEARED OF BLOOD PROMPTLY SINCE SUBSEQUENT SAMPLING WILL BE A TRUE INDEX OF THE EFFECTIVENESS OF HEMORRHAGE CONTROL FROM THE VARICES IN THE ESOPHAGEAL WALL. IF, AFTER CAREFUL LAVAGING OF THE STOMACH FOR 30 MINUTES BRIGHT RED BLEEDING CONTINUES, INCREASE THE ESOPHAGEAL BALLOON PRESSURE TO 45MM OF PRESSURE. AT THE SAME TIME, CONTINUE TO WASH THE STOMACH WITH WATER SO THAT THE MOMENT BLEEDING IS CONTROLLED, IT WILL BE DETECTED. UNDER NORMAL CIRCUMSTANCES ESOPHAGEAL BALLOON PRESSURE SHOULD NOT EXCEED 45MM OF MERCURY, AND IT IS NOT UNCOMMON FOR A PATIENT TO COMPLAIN OF SUBSTERNAL PRESSURE AS THE HIGHER PRESSURES IN THE BALLOON ARE REACHED, PARTICULARLY IF THEY ARE REACHED TOO RAPIDLY. WHEN THE BALLOON IS IN THE PROPER POSITION, THE PRESSURE WILL VARY WITH RESPIRATORY MOVEMENTS AND ESOPHAGEAL CONTRACTIONS. OCCASIONALLY THESE VARIATIONS WILL CAUSE THE BALLOON PRESSURE TO RISE TO 70MM OF MERCURY. THE BASE LINE PRESSURE IS THE ONE OF IMPORTANCE, AND NOT THE TRANSIENT PEAK PRESSURES. IF ESOPHAGEAL BALLOON PRESSURE IS MAINTAINED AT 45MM OF MERCURY AND BLEEDING CONTINUES, IT IS SUGGESTIVE OF A GASTRIC WALL VARIX. IN THIS CASE, THE PATIENT IS GIVEN ADDITIONAL SEDATION IF NECESSARY AND THE TUBE IS SNUGGED UP ON THE NOSE FIRMLY AND TAPED SECURELY. FINALLY, THE GASTRIC BALLOON IS INFLATED WITH MORE AIR GRADUALLY UP TO A TOTAL OF 300-400CC OF AIR. WARNING: THIS DEGREE OF PRESSURE CAUSES ULCERATION OF THE MUCOSA WITHIN A FEW HOURS; THEREFORE, PATIENT MUST BE PREPARED FOR SUTURE OF THE GASTRIC VARICES AS SOON AS THE GENERAL CONDITION PERMITS. AFTER THE MINIMAL PRESSURE IN THE ESOPHAGEAL BALLOON HAS BEEN DETERMINED BY EVIDENCE OF CONTROL OF BLEEDING, CLAMP THE TUBING AS INDICATED IN THE DIAGRAM TO PREVENT AIR LEAKS. DESPITE THIS PRECAUTION, FREQUENT PRESSURE CHECKS SHOULD BE MADE (EVERY 30-60 MINUTES) TO GUARD AGAINST ANY UNDETECTED AIR LEAKS IN THE SYSTEM. AFTER THE STOMACH HAS BEEN COMPLETELY EVACUATED OF BLOOD, CONNECT THE STOMACH ASPIRATION TUBE TO CONSTANT SUCTION DURING THE FIRST 12 HOURS ONLY. IRRIGATE AND ASPIRATE THE TUBE EVERY 30 MINUTES WITH 50CC OF WARM WATER, AND RECORD COLOR OF ASPIRATED FLUID." (B)(4). THE DEVICE WAS NOT RETURNED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED
IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE (IFU), WAS ALLEGEDLY INADEQUATE. THE COMPLAINANT STATED THAT THE EMERGENCY ROOM STAFF WAS UNABLE TO USE THE DEVICE BECAUSE ADDITIONAL EQUIPMENT WAS NEEDED. THE COMPLAINANT ALSO REPORTED THAT THE INSTRUCTIONS TO OBTAIN ADDITIONAL EQUIPMENT , AS WELL AS HOW TO ASSEMBLE THE DEVICE, WAS ALLEGEDLY NOT EASY TO UNDERSTAND OR LOCATE WITHIN THE IFU, ESPECIALLY DURING AN EMERGENCY SITUATION. THE PATIENT ALLEGEDLY EXPERIENCED RUPTURED ESOPHAGEAL VARICES, WHICH WAS REPORTED AS THE PATIENT'S CAUSE OF DEATH. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED, BEFORE THE DEVICE COULD BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE (IFU), WAS ALLEGEDLY INADEQUATE. THE COMPLAINANT STATED THAT THE EMERGENCY ROOM STAFF WAS UNABLE TO USE THE DEVICE BECAUSE ADDITIONAL EQUIPMENT WAS NEEDED. THE COMPLAINANT ALSO REPORTED THAT THE INSTRUCTIONS TO OBTAIN ADDITIONAL EQUIPMENT , AS WELL AS HOW TO ASSEMBLE THE DEVICE, WAS ALLEGEDLY NOT EASY TO UNDERSTAND OR LOCATE WITHIN THE IFU, ESPECIALLY DURING AN EMERGENCY SITUATION. THE PATIENT ALLEGEDLY EXPERIENCED RUPTURED ESOPHAGEAL VARICES, WHICH WAS REPORTED AS THE PATIENT'S CAUSE OF DEATH. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED, BEFORE THE DEVICE COULD BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
IT WAS REPORTED THAT THE EMERGENCY ROOM ALLEGEDLY COULD NOT USE THE BLAKEMORE DEVICE DUE TO THE ADDITIONAL EQUIPMENT NEEDED. THE ADDITIONAL EQUIPMENT LISTED ON THE IFU WAS REPORTEDLY NOT EASILY FOUND DURING AN EMERGENCY SITUATION AND THE DIRECTIONS DID NOT EXPLAIN HOW THE BLAKEMORE SHOULD BE PUT TOGETHER. THE PATIENT WAS EXPERIENCING AN ESOPHAGEAL VARICES. THE PATIENT BLED OUT BEFORE THE DEVICE COULD BE USED. THE CAUSE OF DEATH WAS BLEEDING VARICES. THIS DEVICE WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788443 | BLAKEMORE ESOPHAGEAL-NASOGASTRIC TUBE | BLAKEMORE TUBE | KNT | C.R. BARD, INC. (MONCKS) -1030583 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |