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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; NASOGASTRIC TUBE

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C.R. BARD INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER; NASOGASTRIC TUBE Back to Search Results
Catalog Number 0046160
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/17/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported by customer that the nasogastric tube with filter, 14 french that this was the second og tube that they have found that has a leak at the point where the air vent tubing meets the og tubing.When pushing or flushing medication or fluids some of the liquid comes out between the junction of the two tubes.That means the patient may not get all the solution and medications that were being pushed through the tube.
 
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
 
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Brand Name
BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
Common Device Name
NASOGASTRIC TUBE
Manufacturer (Section D)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key25580608
Report Number1018233-2026-04080
Device Sequence Number9020187
Product Code FEG
UDI-Device Identifier00801741052323
UDI-Public(01)00801741052323(17)301231(10)NGLN2166
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K960176
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Other,Health Professional,User Facility,Company Representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/26/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number0046160
Device Lot NumberNGLN2166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/17/2026
Supplement Date Received by Manufacturer06/26/2026
Initial Report FDA Received Date06/22/2026
Supplement Report FDA Received Date07/08/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age71 YR
Patient SexMale
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