• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ENDURANCE(TM) EXTENDED DWELL PERIPHERAL CATHETER SYSTEM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX INCORPORATED ARROW ENDURANCE(TM) EXTENDED DWELL PERIPHERAL CATHETER SYSTEM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2019
Event Type  malfunction  
Event Description
Picc nurse attempting to place arrow endurance catheter, and wire did not deploy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW ENDURANCE(TM) EXTENDED DWELL PERIPHERAL CATHETER SYSTEM
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville rd
reading PA 19605
MDR Report Key8411493
MDR Text Key138516547
Report Number8411493
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 Risk Manager
Type of Report Initial
Report Date 03/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2019
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/07/2019
Event Location Hospital
Date Report to Manufacturer03/12/2019
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

-
-