MAUDE Adverse Event Report: ARROW TELEFLEX / TELEFLEX MEDICAL ARROW TELEFLEX EPIDURAL KIT; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number AK-005502

Device Problems Break (1069); Defective Device (2588); Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/26/2022

Event Type  malfunction  

Event Description

This incident occurred while placing an epidural using the arrow epidural kit.While placing the epidural, the tuohy needle was advanced like normal until resistance was met.I then went to pull the tuohy needle completely out of the skin to redirect, and the needle completely broke into 2 pieces at the 5 cm mark outside of the patient's back.I then removed the remainder of the needle sticking out from the patient's back without incident.No resistance was met.I then ensured that no other fragments were broken off by putting the two pieced together and measuring the length of the needle from the tip to the hub and made sure all parts were accounted for.This is a piece of defective equipment and could have caused serious harm if the needle broke inside of the patient's back.The pressure applied to the tuohy needle during placement was not excessive, and the needles are supposed to be able to withstand the force applied when placing an epidural.

• Brand Name: ARROW TELEFLEX EPIDURAL KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): ARROW TELEFLEX / TELEFLEX MEDICAL
• MDR Report Key: 16112997
• MDR Text Key: 306889962
• Report Number: MW5114194
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: AK-005502
• Device Lot Number: 37F22H001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American