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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT CATHETER,INTRAVASCULAR,THERAPEUTIC

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TELEFLEX INCORPORATED ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT CATHETER,INTRAVASCULAR,THERAPEUTIC Back to Search Results
Catalog Number CDC-42703-XP1A
Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2019
Event Type  malfunction  
Event Description
Central line kit. After central line placed, physician had difficult removing guidewire. Guidewire removed on one piece. However, the guidewire looked thinned or stripped. Staff did not save product.
 
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Brand NameARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8568355
MDR Text Key143683215
Report Number8568355
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 04/30/2019,04/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-42703-XP1A
Device Lot Number23F19B0118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2019
Event Location Hospital
Date Report to Manufacturer05/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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