LATEX FOLEY CATHETER UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for LATEX FOLEY CATHETER UNK manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[184747528] 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 lot number is unknown; therefore, the device history record could not be reviewed. Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.
Patient Sequence No: 1, Text Type: N, H10


[184747529] It was reported that the foley catheter would not deflate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-02074
MDR Report Key9874497
Report SourceCONSUMER
Date Received2020-03-24
Date of Report2020-03-24
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-24
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 NameLATEX FOLEY CATHETER
Generic NameUNKNOWN CATHETER
Product CodeEZC
Date Received2020-03-24
Catalog NumberUNK
Lot NumberUNK
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
10 2020-03-24

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