MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for NASOGASTRIC SUMP TUBE DUAL LUMEN, WITH RADIOPAQUE STRIPE MARKS 18IN 0042180 manufactured by Productos Para El Cuidado De La Salud -9611590.
[72445203]
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.
Patient Sequence No: 1, Text Type: N, H10
[72445204]
It was reported that the nasogastric tubes were very hard. As a result, the patients were uncomfortable. There was no medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[75940398]
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 states the following: "caution: read all instructions prior to use. Indications for use: bard nasogastric sump tubes are intended to be used for:? Decompression of stomach by suction or aspiration of gastric contents. ? Short-term administration of term tube feeding, lavage fl uid 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. 4. Lubricate the full length of tube to be inserted 5. 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. 6. 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. 7. 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. 8. Secure with a securement device or tape per hospital protocol. 9. Ensure 5-in-1 adapter or lopez valve is snugly inserted into suction lumen to prevent suction loss. 10. Keep blue vent lumen above the level of the patient? S stomach to prevent reflux of stomach fluids into the blue lumen. 11. 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 1. Firmly seat the tapered end of anti-reflux filter in blue air lumen vent of nasogastric tube. 2. If gastric reflux in vent lumen is observed, clear the obstruction in the main lumen by following your hospital? S standard protocol. Attach syringe to luer 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. 3. To cap nasogastric tube when tube is not connected to a suction source insert transport plug on anti-reflux filter housing into suction lumen of nasogastric tube. " (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.
Patient Sequence No: 1, Text Type: N, H10
[75940399]
It was reported that the nasogastric tubes were very hard. As a result, the patients were uncomfortable. There was no medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-01629 |
| MDR Report Key | 6472221 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-05-12 |
| Date Mfgr Received | 2017-04-22 |
| Date Added to Maude | 2017-04-07 |
| 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 | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASOGASTRIC SUMP TUBE DUAL LUMEN, WITH RADIOPAQUE STRIPE MARKS 18IN |
| Generic Name | NG TUBE |
| Product Code | BSS |
| Date Received | 2017-04-07 |
| Catalog Number | 0042180 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Address | KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |