BARDEX? ALL-SILICONE FOLEY CATHETER 165814

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-12 for BARDEX? ALL-SILICONE FOLEY CATHETER 165814 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[186337069] 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


[186337070] It was reported that the catheter balloon inflated asymmetrically (95% to 5%) ratio. The user tried to troubleshoot by inflating and deflating, but the results were the same. Upon arrival of the sample on (b)(6) 2020, there were two catheters packaged together, and a second complaint was opened for the additional catheter mentioned in an email on 20feb2020. It was reported as an asymmetrical balloon as well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01786
MDR Report Key9825326
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-05
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-12
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 NameBARDEX? ALL-SILICONE FOLEY CATHETER
Generic NameSILICONE FOLEY CATHETER
Product CodeGBM
Date Received2020-03-12
Returned To Mfg2020-02-24
Catalog Number165814
Lot NumberNGCX0488
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
10 2020-03-12

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