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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 WITH ENF

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C.R. BARD INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER WITH ENF Back to Search Results
Catalog Number 0046180
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/03/2026
Type of Reportable Event Malfunction
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: sections 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.
 
Event or Problem Description
It was reported that the customer called on behalf of one of her clients, she says that they ordered a case, and on the case, 6 of the ng tube were defected.They were all leaking.
 
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Brand Name
BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER WITH ENF
Common Device Name
NASOGASTRIC SUMP 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 Key25462559
Report Number1018233-2026-03762
Device Sequence Number10284239
Product Code FEG
UDI-Device Identifier00801741052347
UDI-Public(01)00801741052347(17)300531(10)NGKT2580
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
K960176
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Other,Company Representative,Distributor
Initial Reporter Occupation Other Health Care Professional
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 Number0046180
Device Lot NumberNGKT2580
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 06/03/2026
Supplement Date Received by Manufacturer06/25/2026
Initial Report FDA Received Date06/10/2026
Supplement Report FDA Received Date07/09/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured07/26/2025
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 SexUnknown
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