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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) PEDIATRIC TWO LUMEN 4FR 13CM CEN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) PEDIATRIC TWO LUMEN 4FR 13CM CEN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problem Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2021
Event Type  No Answer Provided  
Event Description
Dr. Reported that during the insertion of the central line in the critical pediatric patient there was difficulty threading the guide wire causing it to kink and required opening a second kit to obtain another wire to complete the procedure. Fda safety report id# (b)(4).
 
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Brand NamePEDIATRIC TWO LUMEN 4FR 13CM CEN
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
morrisville NC 27560
MDR Report Key12202344
MDR Text Key262944841
Report NumberMW5102633
Device Sequence Number1
Product Code FOZ
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 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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

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