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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL INC. MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 23F19L0140
Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
We have had numerous instances when the guidewires in the central line kits "kink" and will not advance. This has caused delay in treatment and additional cost to the facility because he have to open 2 (sometimes) 3 kits to get one that will advance.
 
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Brand NameMULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
MDR Report Key10658238
MDR Text Key211060551
Report NumberMW5097174
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
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 10/07/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Lot Number23F19L0140
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
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?
Type of Device Usage

Patient Treatment Data
Date Received: 10/08/2020 Patient Sequence Number: 1
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