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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW ENDURANCE EXTENDED DWELL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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TELEFLEX MEDICAL ARROW ENDURANCE EXTENDED DWELL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number IPN037854
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2019
Event Type  malfunction  
Event Description
Nurse attempted to insert arrow endurance 20g cm extended piv at bedside using us guide wire, inserted into vessel but unable to extract guide wire.They then tried to remove the device completely, but met resistance and were unable to remove the entire device.They then took a scalpel to make a small nick at the puncture site and pull the device out of the pt's arm.Device given to the arrow rep.
 
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Brand Name
ARROW ENDURANCE EXTENDED DWELL
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key8682407
MDR Text Key147464459
Report Number8682407
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 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN037854
Device Catalogue NumberEDC-00620-B
Device Lot Number14F19A0451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2019
Event Location Hospital
Date Report to Manufacturer06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32485 DA
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