MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; ANESTHESIA CONDUCTION KIT

Model Number	IPN040139
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: ARROW
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 9626891
• Report Number: 9626891
• Device Sequence Number: 2396538
• Product Code: CAZ
• UDI-Device Identifier: 50801902126370
• UDI-Public: (01)50801902126370(17)230331(10)13F18C0518
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020
• Report Date (Section F): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN040139
• Device Catalogue Number: EC-05000
• Device Lot Number: 13F18C0518
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 111
• Date Report Sent to FDA: 01/08/2020