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 consumer,distributor,other report with the FDA on 2020-01-06 for BARDEX? ALL-SILICONE FOLEY CATHETER 165814 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[179797162] The reported event was inconclusive, as the device was not returned for evaluation. A potential failure mode could be? Balloon collapses? With a potential root cause of "inflation / drainage lumen wall perforated. " 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: "to deflate catheter balloon: gently insert a syringe in the catheter valve. Never use more force than is required to make the syringe? Stick? In the valve. If you notice slow or no deflation, re-seat the syringe gently. Allow the balloon to deflate slowly on its own. Do not aspirate or manually accelerate the deflation of the balloon. If permitted by hospital protocol, the valve arm may be severed. If this fails, contact adequately trained professional for assistance, as directed by hospital protocol. Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient. "
Patient Sequence No: 1, Text Type: N, H10


[179797163] It was reported that the balloon would not hold the saline.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-00119
MDR Report Key9553661
Report SourceCONSUMER,DISTRIBUTOR,OTHER
Date Received2020-01-06
Date of Report2020-01-06
Date Mfgr Received2019-12-16
Date Added to Maude2020-01-06
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? ALL-SILICONE FOLEY CATHETER
Generic NameSILICONE FOLEY CATHETER
Product CodeGBM
Date Received2020-01-06
Model Number165814
Catalog Number165814
Lot NumberUNK
OperatorLAY USER/PATIENT
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 2020-01-06

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