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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROWGUARD BLU PSI KIT CAT-GARD INJECTION NEEDLE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL ARROWGUARD BLU PSI KIT CAT-GARD INJECTION NEEDLE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number CDC-29903-IA
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2018
Event Type  Injury  
Event Description
Aortic insufficiency procedure, opened product package - noted "burr" cn needle.
 
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Brand NameARROWGUARD BLU PSI KIT CAT-GARD INJECTION NEEDLE
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL
MDR Report Key7391727
MDR Text Key104294208
Report NumberMW5076271
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberCDC-29903-IA
Device Lot Number13F17M0282
Was Device Available for Evaluation? Yes
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: 04/02/2018 Patient Sequence Number: 1
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