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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 NASOGASTRIC TUBE

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER NASOGASTRIC TUBE Back to Search Results
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.
 
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Brand NameBARD® NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER
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 Key12525678
MDR Text Key273109729
Report Number1018233-2021-05935
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 Other,Health Professional,User Facility
Reporter Occupation
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 Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0046140
Device Catalogue Number0046140
Device Lot NumberNGFP1769
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2022
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 Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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