RADIAL ARTERY PRESSURE MONITORING SET N/A C-PMS-250-RA

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 RADIAL ARTERY PRESSURE MONITORING SET N/A C-PMS-250-RA manufactured by Cook Inc.

Event Text Entries

[181223283] Date of event: 2016. Initial reporter - occupation: unknown. Pma/510(k) #: preamendment. (b)(4). 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


[181223284] It was reported that the catheter of a radial artery pressure monitoring set fractured at the hub. As a result, the patient had to go to ir under anesthesia to have the device removed. No other adverse effects have been reported. Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00488
MDR Report Key9765287
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-27
Date of Report2020-02-27
Date Mfgr Received2020-02-13
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. 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 NameRADIAL ARTERY PRESSURE MONITORING SET
Generic NameDQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
Product CodeDQO
Date Received2020-02-27
Model NumberN/A
Catalog NumberC-PMS-250-RA
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Required No Informationntervention 2020-02-27

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