MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER

Catalog Number	0046160
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
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: 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.
Event or Problem Description
It was reported that primary rn placed nasogastric tube (bard nasogastric sump tube order number (b)(4)) lot number ngjw3715, 16 french.The nasogastric tube would not work when connected to suction.Primary rn called cn and cn inspected tube.Manufacture malfunction to tube at the base of the fluid reflux tube.Cn asked patient if we could place another tube and patient did not want another tube placed.Cn explained situation and patient still did not want another tube placed.Cn cut tube proximal to malfunction to obtain patent suction.The nasogastric tube had a hole at the base of the backflow valve.This did not allow suction due to it being an open and not closed system.To quickly provide pain relief by decompressing the stomach it was determined to cut the tube proximal to the manufacture defect to create a closed suction system.The partial tube (distal end) is at the cn station in a biohazard bag.This portion of the tube has the defect.As a side note, the nasogastric tube was replaced about 45 min later to a new tube and there were no issues with the new nasogastric tube.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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.
Event or Problem Description
It was reported that primary rn placed nasogastric tube (bard nasogastric sump tube order number (b)(4)) lot number ngjw3715, 16 french.The nasogastric tube would not work when connected to suction.Primary rn called cn and cn inspected tube.Manufacture malfunction to tube at the base of the fluid reflux tube.Cn asked patient if we could place another tube and patient did not want another tube placed.Cn explained situation and patient still did not want another tube placed.Cn cut tube proximal to malfunction to obtain patent suction.The nasogastric tube had a hole at the base of the backflow valve.This did not allow suction due to it being an open and not closed system.To quickly provide pain relief by decompressing the stomach it was determined to cut the tube proximal to the manufacture defect to create a closed suction system.The partial tube (distal end) is at the cn station in a biohazard bag.This portion of the tube has the defect.As a side note, the nasogastric tube was replaced about 45 min later to a new tube and there were no issues with the new nasogastric tube.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
• 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 30014 ; 7707846100
• MDR Report Key: 21730686
• Report Number: 1018233-2025-02128
• Device Sequence Number: 21016421
• Product Code: FEG
• UDI-Device Identifier: 00801741052323
• UDI-Public: (01)00801741052323(17)290831(10)NGJW3715
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K960176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Number: 0046160
• Device Lot Number: NGJW3715
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/23/2025
• 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 Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male