ZOLL IVTM QUATTRO CATHETER IC-4593 8700-0783-01

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 2020-02-27 for ZOLL IVTM QUATTRO CATHETER IC-4593 8700-0783-01 manufactured by Zoll Circulation.

Event Text Entries

[184420482] Zoll has not received the product for investigation. A follow-up report will be submitted when the product is returned and investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


[184420483] During ivtm therapy, 14 minutes after placement of the quattro catheter (lot # unknown), the user noticed blood in the start-up kit (suk) tubing due to suspecting catheter leak. The quattro catheter was removed and replaced. No further information was provided. No consequences or impact to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010617000-2020-00186
MDR Report Key9765195
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-27
Date of Report2020-02-27
Date Mfgr Received2020-02-04
Date Added to Maude2020-02-27
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 ContactMS. KIM THOA NGUYEN
Manufacturer Street2000 RINGWOOD AVE.
Manufacturer CitySAN JOSE, CA
Manufacturer CountryUS
Manufacturer Phone4192922
Manufacturer G1ZOLL CIRCULATION
Manufacturer Street2000 RINGWOOD AVE.
Manufacturer CitySAN JOSE, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZOLL IVTM QUATTRO CATHETER
Generic NameCENTRAL VENOUS CATHETER
Product CodeNCX
Date Received2020-02-27
Model NumberIC-4593
Catalog Number8700-0783-01
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZOLL CIRCULATION
Manufacturer Address2000 RINGWOOD AVE. SAN JOSE, CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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