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

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 331919157
• Report Number: 1018233-2023-09474
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741113857
• UDI-Public: (01)00801741113857
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other