BARDEX? LUBRICATH? TEMPERATURE-SENSING URINE METER FOLEY TRAY 909116M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-13 for BARDEX? LUBRICATH? TEMPERATURE-SENSING URINE METER FOLEY TRAY 909116M manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[183539818] The reported event was inconclusive, as the device was not returned for evaluation. However, a potential root cause for this failure mode could be kink inlet tube/no air vent/design issue. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "precautions for use (23) avoid force on the connecting parts as they may be accidentally disconnect due to the weight of the drainage bag etc. And may cause urine spill. "
Patient Sequence No: 1, Text Type: N, H10


[183539819] It was reported that the urine did not flow properly from the inlet tube into the drain bag meter on the second day after placement. The patient complained of abdominal pain. The user tried to move the tube but was concerned due to the patients complaint of pain. So far there were about 30 such events. Per additional information from the ibc via email on 26feb2020, after the drain bag was replaced the urine flowed freely and the patient had no more pain. There was no further medical intervention required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01818
MDR Report Key9832522
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2020-02-20
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-13
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 NameBARDEX? LUBRICATH? TEMPERATURE-SENSING URINE METER FOLEY TRAY
Generic NameURINE DRAINAGE BAG (CONOD)
Product CodeEZC
Date Received2020-03-13
Catalog Number909116M
Lot NumberUNK
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 2020-03-13

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