BARDEX? LUBRI-SIL? ALL-SILICONE TEMP SENSING FOLEY CATHETER 119208M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for BARDEX? LUBRI-SIL? ALL-SILICONE TEMP SENSING FOLEY CATHETER 119208M manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[186334634] 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


[186334635] It was reported that the 8 fr temp-sensing foley was found to be not patent after attempted insertion in a patient. Per additional information received, the foley did not drain. When the urologist came to assist, he examined the foley after the removal and there was no hole in the end of the foley for the urine to drain out.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01959
MDR Report Key9856402
Report SourceDISTRIBUTOR,OTHER
Date Received2020-03-19
Date of Report2020-03-19
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-19
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? LUBRI-SIL? ALL-SILICONE TEMP SENSING FOLEY CATHETER
Generic NameTEMP SENSING FOLEY
Product CodeEZL
Date Received2020-03-19
Model Number119208M
Catalog Number119208M
Lot NumberNGDU1415
Device AvailabilityY
Device Eval'ed by Mfgr*
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 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.