BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER 0046180

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for BARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER 0046180 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[135516922] The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[135516923] It was reported that the patient coughed and the ng tube leaked. The leak occurred at the indented portion of the tube, where the blue air vent connects to the sump tube. The complainant noted that at the time of the leak, the tube was not fully inserted and that the coughing was a response to the placement of the tube.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2019-00668
MDR Report Key8311264
Date Received2019-02-06
Date of Report2019-05-09
Date Mfgr Received2019-05-02
Date Added to Maude2019-02-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBARD? NASOGASTRIC SUMP TUBE WITH PREVENT? ANTI-REFLUX FILTER
Generic NameNG TUBE
Product CodeFEG
Date Received2019-02-06
Returned To Mfg2019-02-11
Model Number0046180
Catalog Number0046180
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-06

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