BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿
Report
- Report Number
- 1018233-2023-03895
- Event Type
- Malfunction
- Date Received
- May 31, 2023
- Date of Event
- May 9, 2023
- Report Date
- July 21, 2023
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- BSS
- UDI-DI
- 00801741113789
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INADEQUATE MATERIAL SELECTION DURING DESIGN PHASE, WALL THICKNESS OF TUBE NOT ADEQUATE TO MAINTAIN SUCTION". IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES THE FOLLOWING: INDICATIONS FOR USE: BARD® NASOGASTRIC SUMP TUBES WITH ENFIT¿ CONNECTOR ARE INTENDED TO BE USED FOR: ¿ DECOMPRESSION OF STOMACH BY SUCTION OR ASPIRATION OF GASTRIC CONTENTS. ¿ SHORT-TERM ADMINISTRATION OF TERM TUBE FEEDING, LAVAGE FLUID AND MEDICATIONS. CONTRAINDICATIONS: ¿ PATIENTS WITH KNOWN TAPE OR ADHESIVE ALLERGIES. WARNINGS 1. USE WITH CAUTION IN PATIENTS WITH A HISTORY OF HEAD TRAUMA, FACIAL TRAUMA, ESOPHAGEAL DISEASES AND PATIENTS WITH POTENTIAL FOR VOMITING. 2. DO NOT FORCE NASOGASTRIC TUBE DURING INSERTIONS; DAMAGE TO THE NASAL PASSAGE AND MUCOSA AND BLEEDING MAY OCCUR. 3. MEASURE INSERTION LENGTH CAREFULLY- EXCESSIVE INSERTION LENGTH OF TUBE INTO THE STOMACH MAY LEAD TO COILING AND/OR FORMATION OF TUBE-KNOT. 4. LUBRICATE THE TUBE GENEROUSLY WITH WATER SOLUBLE LUBRICANT PRIOR TO INSERTION. DO NOT USE PETROLEUM-BASED PRODUCTS AS THEY MAY BE HARMFUL TO THE RESPIRATORY TRACT. 5. REFLUX OF GASTRIC CONTENTS INTO THE BLUE VENT LUMEN INDICATES THAT THE SUCTION LUMEN IS OBSTRUCTED OR SUCTION IS TOO LOW. ROUTINELY CHECK FOR REFLUX IN THE BLUE VENT LUMEN AND CLEAR AS PER APPLICABLE DIRECTIONS. FAILURE TO CLEAR THE OBSTRUCTION OR CLEAR PREVENT® FILTER MAY CAUSE GAS & FLUID BUILDUP IN STOMACH, ASPIRATION OF GASTRIC CONTENTS, ASPIRATION PNEUMONIA AND OTHER COMPLICATIONS. 6. DO NOT INJECT FLUID THROUGH THE PREVENT® FILTER AS THIS MAY RESULT IN BLOCKAGE AND LEAKAGE OF FILTER. 7. MONITOR PATIENT FOR NASAL EROSION, SINUSITIS, ESOPHAGITIS, ESOPHAGOTRACHEAL FISTULA, GASTRIC EROSION AND PULMONARY & ORAL INFECTIONS. STATLOCK® NASOGASTRIC STABILIZATION DEVICE: AVOID CONTACT WITH ALCOHOL OR ACETONE; BOTH CAN WEAKEN BONDING OF COMPONENTS AND STATLOCK® STABILIZATION DEVICE PAD ADHERENCE. INSTRUCTIONS FOR NASOGASTRIC TUBE INSERTION 1. EXPLAIN THE PROCEDURE TO THE PATIENT. 2. CAREFULLY MEASURE TO FIND DESIRED LENGTH OF THE TUBE USING THE NASOGASTRIC TUBE AS A MEASUREMENT AID. TO DETERMINE THE INSERTION LENGTH: MEASURE THE TUBE FROM THE TIP OF THE NOSE TO THE EARLOBE AND FROM THE EARLOBE TO THE TIP OF THE XIPHOID PROCESS. MARK THE LENGTH OF THE TUBE TO BE PASSED WITH A SMALL PIECE OF TAPE. 3. CHECK THE PATIENT¿S NOSTRILS FOR PATENCY; SELECT THE NOSTRIL WITH BEST PATENCY. CAUTION: INSTRUCTIONS FOR THE STATLOCK® NASOGASTRIC STABILIZATION DEVICE (WHEN INCLUDED): REMOVE OIL AND MOISTURIZER FROM TARGETED SKIN AREA. APPLY SKIN PREP TO TARGETED STATLOCK® STABILIZATION DEVICE AREA FOR SKIN PROTECTION AND ENHANCED PAD ADHERENCE. ALLOW TO DRY COMPLETELY. NOTE: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE POUCH WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. SINGLE USE. DO NOT RE-STERILIZE. CORRECTION- E 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 INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INADEQUATE MATERIAL SELECTION DURING DESIGN PHASE, WALL THICKNESS OF TUBE NOT ADEQUATE TO MAINTAIN SUCTION". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INDICATIONS FOR USE: BARD® NASOGASTRIC SUMP TUBES WITH ENFIT¿ CONNECTOR ARE INTENDED TO BE USED FOR: ¿ DECOMPRESSION OF STOMACH BY SUCTION OR ASPIRATION OF GASTRIC CONTENTS. ¿ SHORT-TERM ADMINISTRATION OF TERM TUBE FEEDING, LAVAGE FLUID AND MEDICATIONS. CONTRAINDICATIONS: ¿ PATIENTS WITH KNOWN TAPE OR ADHESIVE ALLERGIES. WARNINGS 1. USE WITH CAUTION IN PATIENTS WITH A HISTORY OF HEAD TRAUMA, FACIAL TRAUMA, ESOPHAGEAL DISEASES AND PATIENTS WITH POTENTIAL FOR VOMITING. 2. DO NOT FORCE NASOGASTRIC TUBE DURING INSERTIONS; DAMAGE TO THE NASAL PASSAGE AND MUCOSA AND BLEEDING MAY OCCUR. 3. MEASURE INSERTION LENGTH CAREFULLY- EXCESSIVE INSERTION LENGTH OF TUBE INTO THE STOMACH MAY LEAD TO COILING AND/OR FORMATION OF TUBE-KNOT. 4. LUBRICATE THE TUBE GENEROUSLY WITH WATER SOLUBLE LUBRICANT PRIOR TO INSERTION. DO NOT USE PETROLEUM-BASED PRODUCTS AS THEY MAY BE HARMFUL TO THE RESPIRATORY TRACT. 5. REFLUX OF GASTRIC CONTENTS INTO THE BLUE VENT LUMEN INDICATES THAT THE SUCTION LUMEN IS OBSTRUCTED OR SUCTION IS TOO LOW. ROUTINELY CHECK FOR REFLUX IN THE BLUE VENT LUMEN AND CLEAR AS PER APPLICABLE DIRECTIONS. FAILURE TO CLEAR THE OBSTRUCTION OR CLEAR PREVENT® FILTER MAY CAUSE GAS & FLUID BUILDUP IN STOMACH, ASPIRATION OF GASTRIC CONTENTS, ASPIRATION PNEUMONIA AND OTHER COMPLICATIONS. 6. DO NOT INJECT FLUID THROUGH THE PREVENT® FILTER AS THIS MAY RESULT IN BLOCKAGE AND LEAKAGE OF FILTER. 7. MONITOR PATIENT FOR NASAL EROSION, SINUSITIS, ESOPHAGITIS, ESOPHAGOTRACHEAL FISTULA, GASTRIC EROSION AND PULMONARY & ORAL INFECTIONS. STATLOCK® NASOGASTRIC STABILIZATION DEVICE: AVOID CONTACT WITH ALCOHOL OR ACETONE; BOTH CAN WEAKEN BONDING OF COMPONENTS AND STATLOCK® STABILIZATION DEVICE PAD ADHERENCE. INSTRUCTIONS FOR NASOGASTRIC TUBE INSERTION 1. EXPLAIN THE PROCEDURE TO THE PATIENT. 2. CAREFULLY MEASURE TO FIND DESIRED LENGTH OF THE TUBE USING THE NASOGASTRIC TUBE AS A MEASUREMENT AID. TO DETERMINE THE INSERTION LENGTH: MEASURE THE TUBE FROM THE TIP OF THE NOSE TO THE EARLOBE AND FROM THE EARLOBE TO THE TIP OF THE XIPHOID PROCESS. MARK THE LENGTH OF THE TUBE TO BE PASSED WITH A SMALL PIECE OF TAPE. 3. CHECK THE PATIENT¿S NOSTRILS FOR PATENCY; SELECT THE NOSTRIL WITH BEST PATENCY. CAUTION: INSTRUCTIONS FOR THE STATLOCK® NASOGASTRIC STABILIZATION DEVICE (WHEN INCLUDED): REMOVE OIL AND MOISTURIZER FROM TARGETED SKIN AREA. APPLY SKIN PREP TO TARGETED STATLOCK® STABILIZATION DEVICE AREA FOR SKIN PROTECTION AND ENHANCED PAD ADHERENCE. ALLOW TO DRY COMPLETELY. NOTE: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE POUCH WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. SINGLE USE. DO NOT RE-STERILIZE." CORRECTION- D. 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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: THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES WHEN USED FOR SUCTION. STATED THAT IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES AND THEY HAVE REACHED OUT TO THEIR AHS PARTNERS, AND THEY ALSO SEEM TO HAVE THE SAME ISSUE. AS PER FOLLOW-UP VIA EMAIL ON 23MAY2023, IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES EN0042180 (12FR, 14FR, 16FR) WHEN USED FOR SUCTION. IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES.
IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES WHEN USED FOR SUCTION. STATED THAT IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES AND THEY HAVE REACHED OUT TO THEIR AHS PARTNERS, AND THEY ALSO SEEM TO HAVE THE SAME ISSUE. AS PER FOLLOW-UP VIA EMAIL ON 23MAY2023, IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES EN0042180 (12FR, 14FR, 16FR) WHEN USED FOR SUCTION. IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES.
IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES WHEN USED FOR SUCTION. STATED THAT IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES AND THEY HAVE REACHED OUT TO THEIR AHS PARTNERS, AND THEY ALSO SEEM TO HAVE THE SAME ISSUE. PER FOLLOW-UP VIA EMAIL ON 23MAY2023, IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES EN0042180 (12FR, 14FR, 16FR) WHEN USED FOR SUCTION. IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029677 | BARD® NASOGASTRIC SUMP TUBE WITH ENFIT¿ | NASOGASTRIC SUMP TUBE | BSS | C.R. BARD, INC. (COVINGTON) -1018233 | EN0042180 | UNK | 00801741113789 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |