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

Catalog Number	EN0056140
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
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.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 the currently stocked bard sump nasogastric tubes were not draining appropriately when connected to suction drainage.Customer was told of up to 4 instances where the tube had to be replaced shortly after being placed due to clogging or not draining.This resulted in delays in care for their patient (i.E.Drainage of stomach contents), and dissatisfaction with multiple invasive procedures to replace tubes, not to mention the additional x-rays exposure required to verify tube placement.Compared to the covidien ng salem sump tubes customer had been using, the size of the hole to allow drainage from suction was significantly smaller in the bard.There was another set of staff with the same concerns.Customer had multiple areas expressed concerns with the bard sub for the nasogastric tubes.Customer thought the bard tube should be pulled from use immediately.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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 the currently stocked bard sump nasogastric tubes were not draining appropriately when connected to suction drainage.Customer was told of up to 4 instances where the tube had to be replaced shortly after being placed due to clogging or not draining.This resulted in delays in care for their patient (i.E.Drainage of stomach contents), and dissatisfaction with multiple invasive procedures to replace tubes, not to mention the additional x-rays exposure required to verify tube placement.Compared to the covidien ng salem sump tubes customer had been using, the size of the hole to allow drainage from suction was significantly smaller in the bard.There was another set of staff with the same concerns.Customer had multiple areas expressed concerns with the bard sub for the nasogastric tubes.Customer thought the bard tube should be pulled from use immediately.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE AND PREVENT® FILTER AND LOPEZ VALVE® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18445706
• Report Number: 1018233-2023-09474
• Device Sequence Number: 17849064
• Product Code: FEG
• UDI-Device Identifier: 00801741113857
• UDI-Public: (01)00801741113857
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: EN0056140
• Device Lot Number: NGGP3242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/23/2024
• 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