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

Model Number 0046140

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event 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.

Manufacturer Narrative

Upon further review, bd has determined that this event is not reportable.

Event 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
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12525678
• MDR Text Key: 273109729
• Report Number: 1018233-2021-05935
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052316
• UDI-Public: (01)00801741052316
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/24/2022
• 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