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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. PRESSURE MONITORING TRAY CATHETER, PERCUTANEOUS

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COOK, INC. PRESSURE MONITORING TRAY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number G02854
Device Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2019
Event Type  Injury  
Event Description

In placing an arterial line on this pt, i discovered that the introducer needle included in the kit was faulty with an occluded lumen. As a result, attempts to cannulate the artery with this device were unsuccessful causing potential harm. Fda safety report id# (b)(4).

 
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Brand NamePRESSURE MONITORING TRAY
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK, INC.
MDR Report Key9353997
MDR Text Key167555834
Report NumberMW5091209
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 11/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/23/2020
Device Catalogue NumberG02854
Device LOT Number9001278
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/20/2019 Patient Sequence Number: 1
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