• 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 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
 

TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN040139
Device Problems Defective Device (2588); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2019
Event Type  malfunction  
Event Description
There was 2 catheters which are defective; one was bent and the second one shredded. Per the doctor's operative note: preop diagnosis: cervical radiculopathy. Postop diagnosis: cervical radiculopathy. Procedure planned: epidural steroid injection at the c7-t1 interspace, fluoroscopic guidance. The site of pain and procedure were confirmed prior to starting the procedure. The target interspace was identified. The skin overlying the target area was prepped with chlorhexidine and sterilely draped. Local anesthesia was obtained with 3. 0 ml of preservative free 1% lidocaine. Using a 20-gauge tuohy needle with a loss-of-resistance to normal saline and hanging drop technique, the epidural space was located. Aspiration was negative for blood or csf. Subsequently 1 ml of lopamidol 240m contrast was injected demonstrating appropriate epidural spread. Local anesthetic test dose was negative for intrathecal injection. 10mg dexamethasone was suspended in 4ml of preservative free normal saline was easily injected into the epidural space without apparent complication. The tuohy needle was then cleared with preservative free 1% lidocaine and removed. The skin was cleansed and the patient returned to the supine position. The patient was stable throughout the procedure. Epidural spread was observed up to about c5 level based on contrast, catheter was not inserted although this was initially planned given difficulties experienced with the arrow catheter kit. The patient was observed following the procedure and was then discharged in stable condition with a driver. The patient received post-procedure discharge instructions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key9626891
MDR Text Key176245575
Report Number9626891
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 Other Health Care Professional
Type of Report Initial
Report Date 01/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN040139
Device Catalogue NumberEC-05000
Device Lot Number13F18C0518
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2020
Event Location Hospital
Date Report to Manufacturer01/24/2020
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

-
-