BARDIA? FOLEY CATHETER SILICONE COATED 123616A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-18 for BARDIA? FOLEY CATHETER SILICONE COATED 123616A manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[188334490] The reported event was inconclusive, as the device was not returned for evaluation. However, the potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/ collapse lumen/ sac close eye/ valve damage. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "caution: this product contains natural rubber latex which may cause allergic reactions. Sterile unless package is opened or damaged warning: do not use ointments or lubricants having a petrolatum base. They will damage latex and may burst balloon. Do not aspirate urine through drainage funnel wall. Single use only. Do not resterilize. For urological use only. Valve type: use luer syringe. Do not use needle. 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. Use only gentle aspiration to encourage deflation if needed. Vigorous aspiration may collapse the inflation lumen. If permitted by hospital protocol, the may be cut off. If this fails, contact an 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


[188334491] It was reported that the catheter was difficult to deflate on the 6th day after placement. The doctor was able to remove the catheter by inserting a guidewire into the urethra to pierce the catheter balloon, but this action caused an injury to the wall of the urethra. Then the guidewire was used through the inflation lumen to clear the occlusion, and remove the catheter. The removed catheter balloon was intact, but the patient experience increased pain through the process. Per additional information from the ibc via email 09mar2020, the events reported above were confirmed as correct from the complainant. No additional medical intervention was done for the injured urethral wall or for the increased pain.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-01884
MDR Report Key9848491
Report SourceOTHER
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-01-07
Date Mfgr Received2020-02-25
Device Manufacturer Date2018-02-21
Date Added to Maude2020-03-18
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 NameBARDIA? FOLEY CATHETER SILICONE COATED
Generic NameBARDIA 2 WAY CATHETER
Product CodeKOD
Date Received2020-03-18
Catalog Number123616A
Lot NumberMYCPRC34
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
101. Required No Informationntervention 2020-03-18

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