BARD? CLOSED SYSTEM URINARY DRAINAGE BAG N153504

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-13 for BARD? CLOSED SYSTEM URINARY DRAINAGE BAG N153504 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[183257299] 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


[183257300] It was reported that the anti-reflux valve was allegedly obstructed and there was no urine in the bag. The caregiver tried unclipping at the bottom to open the flow, but that did not work. Next they separated the bag from the foley then lifted the tubing to see if it would drain and jiggled the bulb to no avail. The bag remained dry.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01031
MDR Report Key9708016
Report SourceCONSUMER,OTHER
Date Received2020-02-13
Date of Report2020-03-23
Date Mfgr Received2020-03-19
Device Manufacturer Date2019-10-23
Date Added to Maude2020-02-13
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 Report3

Device Details

Brand NameBARD? CLOSED SYSTEM URINARY DRAINAGE BAG
Generic NameCANADA URINE BAG
Product CodeKNX
Date Received2020-02-13
Returned To Mfg2020-01-28
Catalog NumberN153504
Lot NumberNGDW0574
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 2020-02-13

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