LTXFR CYSTOSCOPY IRR UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for LTXFR CYSTOSCOPY IRR UNKNOWN manufactured by Icu Medical Costa Rica Ltd..

Event Text Entries

[186806381] It is unknown if the device is available for investigation.
Patient Sequence No: 1, Text Type: N, H10


[186806382] The event involved a ltxfr cystoscopy irr where the prong of the continuous bladder irrigation tubing set broke off after the bag was spiked and the prong was seen floating in the fluid of the bag. There was patient involvement, but the broken prong was noticed and the tubing or bag changed out before it reached the patient. There were no fragments passing through the tubing set. There was no adverse event, no delay in critical therapy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615050-2020-00050
MDR Report Key9882511
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-03
Date of Event2020-02-18
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTOPHER ZANONI
Manufacturer Street600 N. FIELD DR.
Manufacturer CityLAKE FOREST IL 60045
Manufacturer CountryUS
Manufacturer Postal60045
Manufacturer Phone2247062300
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLTXFR CYSTOSCOPY IRR
Generic NameCATHETER, IRRIGATION
Product CodeGBX
Date Received2020-03-26
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL COSTA RICA LTD.
Manufacturer AddressZONA FRANCA GLOBAL LA AURORA HEREDIA CS


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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