BARD? URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER 154002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-01-03 for BARD? URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER 154002 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[178331376] 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


[178331377] It has been reported that there were many instances where the urinary drainage bag allegedly "air locked", which prevented the urine to drain from the bladder into the bag. It lead to discomfort for the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-00104
MDR Report Key9548868
Report SourceOTHER,USER FACILITY
Date Received2020-01-03
Date of Report2020-01-07
Date of Event2019-12-08
Date Mfgr Received2020-01-05
Device Manufacturer Date2019-07-05
Date Added to Maude2020-01-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Report3

Device Details

Brand NameBARD? URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
Generic NameDRAIN BAG
Product CodeKNX
Date Received2020-01-03
Catalog Number154002
Lot NumberNGDS3524
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2020-01-03

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