FOLY CATH 100 SLCON 3CC 8FR 8887603085

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-10 for FOLY CATH 100 SLCON 3CC 8FR 8887603085 manufactured by Covidien.

Event Text Entries

[182918414] The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.? As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10


[182918415] The customer reported that the tip of the catheter broke off and was not straight. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2020-08965
MDR Report Key9814079
Report SourceUSER FACILITY
Date Received2020-03-10
Date of Report2020-03-17
Date of Event2020-02-11
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-10
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFOLY CATH 100 SLCON 3CC 8FR
Generic NameTRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
Product CodeFCM
Date Received2020-03-10
Model Number8887603085
Catalog Number8887603085
Lot Number9179187
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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