MAUDE Adverse Event Report: C. R. BARD, INC. BARD® NASOGASTRIC SUMP TUBE; TUBE, NASOGASTRIC

Model Number	0042100
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vomiting (2144)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Peds patient who the staff called the doctor about because of continued bleeding and vomiting.The peds patient had an bard nasogastric sump tube.An x-ray was completed, the doctor noted that the bard nasogastric sump tube was coiled in the esophagus.When the peds staff removed the bard nasogastric sump tube, it looked like there was a defect at the bottom at one of the holes.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE
• Common Device Name: TUBE, NASOGASTRIC
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 14117759
• Report Number: 14117759
• Device Sequence Number: 14060302
• Product Code: BSS
• UDI-Device Identifier: 00801741052231
• UDI-Public: (01)00801741052231
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/07/2022
• Report Date (Section F): 03/07/2022

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
• Device Model Number: 0042100
• Device Catalogue Number: 0042100
• Device Lot Number: NGEY2713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 03/07/2022