BARDEX? I.C. TEMPERATURE SENSING FOLEY CATHETER 129414M

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 2020-03-25 for BARDEX? I.C. TEMPERATURE SENSING FOLEY CATHETER 129414M manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[188206534] 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


[188206535] It was reported that the catheter balloon was difficult to deflate on the second day of use. It was stated that they tried to pump the syringe and cut the inflation lumen and then the catheter shaft, but the water would not come out. Next a guidewire was used to try and clear the lumen and then to try to burst the balloon, but it did not work either. Last, the water was able to be removed by the urologist. The original sample was discarded, however 6 lot samples were to be sent in for testing. Per additional information from the ibc via email 11mar2020, the urologist used percutaneous puncture and there were no missing pieces to the burst balloon. No additional medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-02102
MDR Report Key9880116
Report SourceDISTRIBUTOR,OTHER
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-01
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-25
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? I.C. TEMPERATURE SENSING FOLEY CATHETER
Generic NameFOLEY CATHETER (LATEX)
Product CodeMJC
Date Received2020-03-25
Returned To Mfg2020-03-20
Catalog Number129414M
Lot NumberMYDV3402
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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
101. Required No Informationntervention 2020-03-25

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