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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 BARD NASOGASTRIC SUMP TUBE WITH PREVENT ANTI-REFLUX FILTER WITH ENENFIT NASOGASTRIC TUBE Back to Search Results
Model Number 0046160
Device Problem Biocompatibility (2886)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  Injury  
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 when the nasogastric tube was placed, it punctured the patient's esophagus. It was unknown what medical intervention was provided.
 
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Brand NameBARD NASOGASTRIC SUMP TUBE WITH PREVENT ANTI-REFLUX FILTER WITH ENENFIT
Type of DeviceNASOGASTRIC 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 Key11673401
MDR Text Key245736633
Report Number1018233-2021-02131
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0046160
Device Catalogue Number0046160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/15/2021 Patient Sequence Number: 1
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