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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 CENTRAL VENOUS CATHETER, SHORT-TERM LESS THAN 30 DAYS

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TELEFLEX INCORPORATED ARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT CENTRAL VENOUS CATHETER, SHORT-TERM LESS THAN 30 DAYS 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 04/25/2019
Event Type  malfunction  
Event Description
Arrow multi-lumen central venous catheterization kit. After placement of central line, physician noted difficulty removing guidewire. Physician was able to remove guidewire which looks thinned and stripped. This is the second similar event at this facility with this device within one week. Manufacturer notified and device returned. Manufacturer response for central line kit, arrow multi-lumen central venous catheterization kit (per site reporter). Teleflex customer service contacted. Product picked up teleflex medical sales representative.
 
Event Description
Sc-1132 (sn: 134615) device evaluation indicated that the ipg passed all tests performed.
 
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Brand NameARROW MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
Type of DeviceCENTRAL VENOUS CATHETER, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8573110
MDR Text Key143834092
Report Number8573110
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,Followup
Report Date 04/30/2019,04/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-42703-XP1A
Device Lot Number23F19B0118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
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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