BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿
Report
- Report Number
- 1018233-2023-08556
- Event Type
- Malfunction
- Date Received
- November 28, 2023
- Date of Event
- March 13, 2023
- Report Date
- May 30, 2024
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- BSS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
THE REPORTED EVENT WAS CONFIRMED USE RELATED AS PATIENT WAS NOT PLACING THE TUBE IN PROPER POSITION. A ROOT CAUSE FOR THIS FAILURE COULD BE "USER DEVIATION FROM IFU.". A DHR REVIEW WAS NOT REQUIRED BECAUSE THE INVESTIGATION WAS CONFIRMED - USE RELATED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "KEEP BLUE VENT LUMEN ABOVE THE LEVEL OF THE PATIENT¿S STOMACH TO PREVENT REFLUX OF STOMACH FLUIDS INTO THE BLUE LUMEN". H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.
THE REPORTED EVENT WAS CONFIRMED USE RELATED AS PATIENT WAS NOT PLACING THE TUBE IN PROPER POSITION. A ROOT CAUSE FOR THIS FAILURE COULD BE "USER DEVIATION FROM IFU.". A DHR REVIEW WAS NOT REQUIRED BECAUSE THE INVESTIGATION WAS CONFIRMED - USE RELATED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "KEEP BLUE VENT LUMEN ABOVE THE LEVEL OF THE PATIENT¿S STOMACH TO PREVENT REFLUX OF STOMACH FLUIDS INTO THE BLUE LUMEN". H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE PATIENT HAD NASOGASTRIC TUBE CONNECTED TO LOW INTERMITTENT SUCTION. SUCTION WOULD NOT WORK UNLESS THEY HELD THE TUBE IN A PARTICULAR POSITION AND PARTIALLY UNHOOKED THE NASOGASTRIC TUBE FROM THE SUCTION TUBING. THEY ATTEMPTED TO IRRIGATE THE NASOGASTRIC TUBE, ALSO ATTEMPTED TO USE THE BRUSH DESIGNED FOR THESE TUBES BUT SUCTION STILL ONLY WORKED OCCASIONALLY.
IT WAS REPORTED THAT THE PATIENT HAD NASOGASTRIC TUBE CONNECTED TO LOW INTERMITTENT SUCTION. SUCTION WOULD NOT WORK UNLESS THEY HELD THE TUBE IN A PARTICULAR POSITION AND PARTIALLY UNHOOKED THE NASOGASTRIC TUBE FROM THE SUCTION TUBING. THEY ATTEMPTED TO IRRIGATE THE NASOGASTRIC TUBE, ALSO ATTEMPTED TO USE THE BRUSH DESIGNED FOR THESE TUBES BUT SUCTION STILL ONLY WORKED OCCASIONALLY.
IT WAS REPORTED THAT THE PATIENT HAD NASOGASTRIC TUBE CONNECTED TO LOW INTERMITTENT SUCTION. SUCTION WOULD NOT WORK UNLESS THEY HELD THE TUBE IN A PARTICULAR POSITION AND PARTIALLY UNHOOKED THE NASOGASTRIC TUBE FROM THE SUCTION TUBING. THEY ATTEMPTED TO IRRIGATE THE NASOGASTRIC TUBE, ALSO ATTEMPTED TO USE THE BRUSH DESIGNED FOR THESE TUBES BUT SUCTION STILL ONLY WORKED OCCASIONALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1764977 | BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿ | NASOGASTRIC SUMP TUBE | BSS | C.R. BARD, INC. (COVINGTON) -1018233 | NGFW1855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |