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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW FLEXTIP PLUS EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT

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TELEFLEX INCORPORATED ARROW FLEXTIP PLUS EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN045607
Device Problem Component Missing (2306)
Patient Problem No Code Available (3191)
Event Date 09/19/2019
Event Type  malfunction  
Event Description
Epidural catheter placed by anesthesia. Insertion was uncomplicated. 12 hours later, nurse encountered difficulty upon attempt at catheter removal. Anesthesia called for assistance. Upon catheter removal, tip was not intact. Missing approx. 5cm of catheter tip. Patient required surgical exploration for catheter tip removal four days later.
 
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Brand NameARROW FLEXTIP PLUS EPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd.
morrisville NC 27560
MDR Report Key9744493
MDR Text Key180611199
Report Number9744493
Device Sequence Number1
Product Code CAZ
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 02/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberIPN045607
Device Catalogue NumberAK-05502
Device Lot Number23F19FO158
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/17/2020
Event Location Hospital
Date Report to Manufacturer02/24/2020
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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