YUEH CENTESIS DISPOSABLE CATHETER NEEDLE N/A DTVN-5.0-19-10.0-YUEH

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 2020-01-29 for YUEH CENTESIS DISPOSABLE CATHETER NEEDLE N/A DTVN-5.0-19-10.0-YUEH manufactured by Cook Inc.

Event Text Entries

[177369911] Occupation: purchasing. Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[177369912] It was reported that upon the device being stocked the user found a "hair, believed to be an eyelash" within the closed product packaging. This occurred while stocking and was not during any procedure. No patient contact was made. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00235
MDR Report Key9643918
Report SourceUSER FACILITY
Date Received2020-01-29
Date of Report2020-01-29
Date of Event2020-01-14
Date Mfgr Received2020-01-15
Device Manufacturer Date2019-11-27
Date Added to Maude2020-01-29
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 ContactUNK JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameYUEH CENTESIS DISPOSABLE CATHETER NEEDLE
Generic NameGCB NEEDLE, CATHETER
Product CodeGCB
Date Received2020-01-29
Returned To Mfg2020-01-23
Model NumberN/A
Catalog NumberDTVN-5.0-19-10.0-YUEH
Lot Number10178366
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-29

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