ARROW IPN040139 EC-05000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for ARROW IPN040139 EC-05000 manufactured by Teleflex Incorporated.

Event Text Entries

[176245575] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9626891
• MDR Report Key: 9626891
• Date Received: 2020-01-24
• Date of Report: 2020-01-08
• Date of Event: 2019-12-18
• Report Date: 2020-01-08
• Date Reported to FDA: 2020-01-08
• Date Reported to Mfgr: 2020-01-24
• Date Added to Maude: 2020-01-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARROW
• Generic Name: ANESTHESIA CONDUCTION KIT
• Product Code: CAZ
• Date Received: 2020-01-24
• Model Number: IPN040139
• Catalog Number: EC-05000
• Lot Number: 13F18C0518
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX INCORPORATED
• Manufacturer Address: PO BOX 12600 DURHAM NC 27709 US 27709

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-24