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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER; NG TUBE
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER; NG TUBE Back to Search Results
Model Number 0046160
Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the ng tube was kinked at the end.The hospital had numerous difficulties with numerous patients.In addition, they had difficulty inserting them.The doctor was unable to place one of the ng tubes.Another doctor was able to place one after icing the first 6 cm or so, with some difficulty.The doctor stated that these tubes appear to have multiple openings, with one large one, and they didn't remember there being so many.
 
Manufacturer Narrative
The device was not returned for evaluation.The reported event could not be confirmed.A potential failure mode could be ¿tube kinks¿ with a potential root cause of ¿inadequate material selection during design phase¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state 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.Refl ux of gastric contents into the blue vent lumen indicates that the suction lumen is obstructed or suction is too low.Routinely check for refl ux in the blue vent lumen and clear as per applicable directions.Failure to clear the obstruction or clear prevent® filter may cause gas and fluid buildup in stomach, aspiration of gastric contents, aspiration pneumonia and other complications.6.Do not inject fl uid through the prevent® filter as this may result in blockage and leakage of fi lter.7.Monitor patient for nasal erosion, sinusitis, esophagitis, esophagotracheal fi stula, gastric erosion and pulmonary & oral infections." h11:section a through f - the information provided by bd 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 bd.The device was not returned.
 
Event Description
It was reported that the ng tube was kinked at the end.The hospital had numerous difficulties with numerous patients.In addition, they had difficulty inserting them.The doctor was unable to place one of the ng tubes.Another doctor was able to place one after icing the first 6 cm or so, with some difficulty.The doctor stated that these tubes appear to have multiple openings, with one large one, and they didn't remember there being so many.
 
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Brand Name
BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
Type of Device
NG TUBE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key10004434
MDR Text Key189471473
Report Number1018233-2020-02867
Device Sequence Number1
Product Code FEG
UDI-Device Identifier00801741052323
UDI-Public(01)00801741052323
Combination Product (y/n)N
PMA/PMN Number
K960176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Model Number0046160
Device Catalogue Number0046160
Device Lot NumberNGDP0649
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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