BARD? PREVENT? ANTI-REFLUX FILTER 0046000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-02 for BARD? PREVENT? ANTI-REFLUX FILTER 0046000 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[137814177] The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[137814178] It was reported that the markings on the ng tube had rubbed off. Without the markings, the nursing staff could not determine where the ng tube was inserted, or where it should be located. Additionally, it was alleged that residue remained in the filters after use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2019-01122
MDR Report Key8384358
Date Received2019-03-02
Date of Report2019-04-08
Date Mfgr Received2019-04-01
Device Manufacturer Date2018-08-10
Date Added to Maude2019-03-02
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? PREVENT? ANTI-REFLUX FILTER
Generic NameFILTERS FOR NG TUBE
Product CodeFEG
Date Received2019-03-02
Catalog Number0046000
Lot NumberNGCU4332
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2019-03-02

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