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

MAUDE Adverse Event Report: ARROW/ TELEFLEX INC TELEFLEX EPIDURAL KIT ANESTHESIA CONDUCTION KIT

  • 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
 

ARROW/ TELEFLEX INC TELEFLEX EPIDURAL KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number AK-05000
Device Problems Device Markings/Labelling Problem (2911); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2018
Event Type  Injury  
Event Description
The arrow epidural kit was used on a cse. Placement went easily although there are minimal depth markings on this catheter. Removed catheter at the end of the procedure with slight initial resistance but end that was removed looked like the metal tip of the original catheter. I was contacted by physician approx 2 months later when the patient was having a fluro-guided esi and a foreign body was seen between l2-3 space on fluoro and presumed to be retained epidural catheter. Patient asymptomatic- and recommended follow-up w/ neurosurgeon to see if the foreign body needs removal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTELEFLEX EPIDURAL KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW/ TELEFLEX INC
MDR Report Key8306073
MDR Text Key135678605
Report NumberMW5083691
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAK-05000
Device Catalogue NumberAK-05000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/04/2019 Patient Sequence Number: 1
-
-