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

Model Number	EN0046140
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nasogastric tube did not do what intended in medical setting.The issue with the nasogastric tube was unknown.The product catalog numbers provided by customer were en0046100, en0046120, en0046140, en0046160 and en0046180.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause was not chosen due to a lack of information.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not completed due to a lack of information.The device was not returned.
Event or Problem Description
It was reported that the nasogastric tube did not do what intended in medical setting.The issue with the nasogastric tube was unknown.The product catalog numbers provided by customer were en0046100, en0046120, en0046140, en0046160 and en0046180.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER WITH ENFIT¿
• Common Device Name: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15508466
• Report Number: 1018233-2022-07539
• Device Sequence Number: 6067857
• Product Code: FEG
• UDI-Device Identifier: 00801741113246
• UDI-Public: (01)00801741113246
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: EN0046140
• Device Catalogue Number: EN0046140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown