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

Model Number	0046140
Medical Device Problem Codes	Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
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.
Event or Problem Description
It was reported that there was a malfunction of nasogastric tube.Per follow up received on 30aug2021 the customer stated that on one patient the nasogastric tube leaked the gastric content where the anti reflux port meets the gastric port and another patient there was a continuous whistling sound that came from the same area.It was also stated that the tube removed from the patient and experienced trauma of having another one inserted with the same issue where the placement was confirmed for each insertion.The tube was ultimately removed the second time and the patient refused another insertion which delayed the healing related to the diagnosis.No medical intervention was reported.
Additional Manufacturer Narrative
Upon further review, bd has determined that this event is not reportable.
Event or Problem Description
It was reported that there was a malfunction of nasogastric tube.Per follow up received on 30aug2021 the customer stated that on one patient the nasogastric tube leaked the gastric content where the anti reflux port meets the gastric port and another patient there was a continuous whistling sound that came from the same area.It was also stated that the tube removed from the patient and experienced trauma of having another one inserted with the same issue where the placement was confirmed for each insertion.The tube was ultimately removed the second time and the patient refused another insertion which delayed the healing related to the diagnosis.No medical intervention was reported.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12525678
• Report Number: 1018233-2021-05935
• Device Sequence Number: 13696283
• Product Code: FEG
• UDI-Device Identifier: 00801741052316
• UDI-Public: (01)00801741052316
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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 Expiration Date: 02/28/2026
• Device Model Number: 0046140
• Device Catalogue Number: 0046140
• Device Lot Number: NGFP1769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 05/27/2022
• 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 Sex: Unknown