MAUDE Adverse Event Report: C. R. BARD, INC. BARD® PREVENT® ANTI-REFLUX FILTER; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	0046000
Health Effect - Clinical Codes	Vomiting (2144); Gastrointestinal Regurgitation (4477)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A salem sump nasogastric tube was placed for decompression.The bard prevent anti-reflux filter was placed upside down in the air vent.The tube was not decompressing patient's stomach, and patient was able to vomit around tube.During nursing peer review, it was identified the product's instructions are not clear on way to insert.The instructions state "firmly seat tapered end of anti-reflux filter in blue air lumen vent of ng tube." the registered nurses (rns) involved and other rns asked about the placement of filter felt the package instructions left too room for interpretation and it was not clear.The rns would like more description of insertion blue end into the blue air vent or an arrow to show direction for insertion.Currently the device has a label stating infuse air only.

• Brand Name: BARD® PREVENT® ANTI-REFLUX FILTER
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 19319890
• Report Number: 19319890
• Device Sequence Number: 12656732
• Product Code: FEG
• UDI-Device Identifier: 00801741052286
• UDI-Public: (01)00801741052286
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2024
• Report Date (Section F): 03/13/2024

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: 0046000
• Device Catalogue Number: 0046000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• 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: Unknown
• Date Report Sent to FDA: 03/13/2024