MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-31 for BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER WITH ENFIT? EN0046180 manufactured by C.r. Bard, Inc. (covington) -1018233.
[109766558]
The reported issue could not be confirmed due to poor sample condition of the pictures. During the visual evaluation, a nasogastric tube with enfit connector assembly was noted. The received photos were reviewed and no kinks or obstructions were observed in the pvc tube or the enfit connector that could affect the flow rate or suction during the use. The sample could not be measured or tested since no physical sample was received. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use 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: use with caution in patients with a history of head trauma, facial trauma, esophageal diseases and patients with potential for vomiting. Do not force nasogastric tube during insertions; damage to the nasal passage and mucosa and bleeding may occur. Measure insertion length carefully- excessive insertion length of tube into the stomach may lead to coiling and/or formation of tube-knot. 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. 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. Do not inject fluid through the prevent? Filter as this may result in blockage and leakage of filter. 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: explain the procedure to the patient. 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. Check the patient? S nostrils for patency; select the nostril with best patency. Lubricate the full length of tube to be inserted. Insert the tube through the nose aiming down and back. When the tube hits the pharynx, if patient is able, have him or her flex his/her head forward and swallow. Advance the tube as the patient swallows. If resistance is met, rotating the tube may facilitate placement. Continue to advance the tube until the marked position on the tube is reached. Do not advance beyond the marked length as coiling and or knotting of the tube in the stomach may occur. Confirm tube placement per hospital policy. The tube has a radiopaque stripe facilitating x-ray confirmation. If proper placement of tube within the stomach cannot be confirmed, remove the tube gently and start the procedure again. Secure with a securement device or tape per hospital protocol. If applicable, ensure the lopez valve? With enfit? Connector is snugly inserted into suction lumen to prevent suction loss. Keep blue vent lumen above the level of the patient? S stomach to prevent reflux of stomach fluids into the blue lumen. Do not clamp air vent port while suction is being applied. Recommended suction settings always use lowest suction setting that will effectively decompress the stomach. For intermittent suction via thermotic pump, use? High? (gomco, 120mm hg). For intermittent suction via central source, set at? Low? (30-40mm hg). For continuous suction, set at? Low? (30-40mm hg). Increase slowly until flow is observed as necessary. Instructions for prevent? Anti-reflux filter with enfit? Connector: firmly twist the white base of anti-reflux filter in blue air lumen vent of nasogastric tube. If gastric reflux in vent lumen is observed, clear the obstruction in the main lumen by following your hospital? S standard protocol. Attach enfit? - compatible syringe to enfit? Male fitting on anti-reflux filter and inject a minimum of 15cc of air to clear the blue air vent lumen of any gastric reflux. Do not inject fluid through filter. To cap nasogastric tube when tube is not connected to a suction source insert tethered cap that is attached to the barb in the suction lumen of nasogastric tube. 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 resterilize. " 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.
Patient Sequence No: 1, Text Type: N, H10
[109766559]
It was reported that the ng tube did not suction well. The complainant reported that the "inner moat" of the enfit connector limited the suction. The complainant tested the product without a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-01981 |
| MDR Report Key | 7557526 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2018-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER WITH ENFIT? |
| Generic Name | NG TUBE |
| Product Code | FEG |
| Date Received | 2018-05-31 |
| Returned To Mfg | 2018-05-02 |
| Catalog Number | EN0046180 |
| Lot Number | NGAY2329 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-31 |