GUARDIA? ACCESS EMBRYO TRANSFER CATHETER K-JETS-7019

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-11-30 for GUARDIA? ACCESS EMBRYO TRANSFER CATHETER K-JETS-7019 manufactured by Cook Inc.

Event Text Entries

[129582145] Blank fields on this form indicate the information is unknown or unavailable. Device code: device contaminated during manufacture or shipping is not labeled. 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


[129582146] It was initially reported, an oily substance was found on the inner portion of the catheter prior to use. Additional information received 30nov2018. Further event clarification was provided. The operator checked the device and the issue was discovered prior to use during the preparation stage. The ivf procedure was completed by changing to another device of the same type. There were no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-03448
MDR Report Key8121255
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-11-30
Date of Report2019-01-21
Date of Event2018-11-09
Date Mfgr Received2019-01-18
Device Manufacturer Date2018-07-18
Date Added to Maude2018-11-30
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 ContactMR. LARRY POOL
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 NameGUARDIA? ACCESS EMBRYO TRANSFER CATHETER
Generic NameMQF CATHETER, ASSISTED REPRODUCTION
Product CodeMQF
Date Received2018-11-30
Returned To Mfg2018-12-04
Catalog NumberK-JETS-7019
Lot Number8993738
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-30

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