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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 Problem Difficult to Open or Close (2921)
Patient Problems Nausea (1970); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported that the patient had arrived at the unit on admission with a clamped nasogastric tube from the emergency department and was to be reconnected to low suction for decompression, but the staff were unable to remove the clamp as it was fully lodged into the nasogastric tubing. It was then stated that the nasogastric tube clamp piece which is the white end of the blue or the white clamp piece broke off and was stuck in nasogastric tubing. Complainant stated that it broke quite easily and there was no way to avoid. Later, a metal chest tube clamp was used to remove the piece, although it was difficult. Solving the problem did not leave the patient in harm, but the nasogastric tubing remained intact and attached to low suction with success. However, the patient was becoming increasingly nauseated throughout this time as the patient remained clamped for a prolonged period prior to being able to connect the nasogastric tubing to low suction.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
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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 Key12909008
MDR Text Key281578605
Report Number1018233-2021-07651
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K960176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0046140
Device Catalogue Number0046140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
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: 12/01/2021 Patient Sequence Number: 1
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