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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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TELEFLEX INCORPORATED ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
Lumen leaking.
 
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Brand NameARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key13794782
MDR Text Key287332209
Report Number13794782
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/10/2022,03/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDC-45703-XP1A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/10/2022
Event Location Hospital
Date Report to Manufacturer03/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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