MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. INTRATHECAL CATHETER

Model Number 11823

Device Problem Leak/Splash (1354)

Patient Problems Nausea (1970); Vomiting (2144); Inadequate Pain Relief (2388)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.Device was not returned.Per the instructions for use of the intrathecal catheter, catheter leak is a known possible risk of use of the device.Internal complaint number: (b)(4).

Event Description

Agent contacted technical solutions to report a catheter replacement due to a catheter leak.Agent reported that the patient was experiencing an increase in pain, nausea and vomiting.Agent reported that a cap study was performed and showed a leak in the catheter.Agent reported the cause of the catheter leak is unknown.Agent reported that the patients pump and catheter were replaced.The pump was replaced to reduce the patients exposure to surgery and infection in the future.Agent reported that there was no alleged pump malfunction.Agent reported that the pump and catheter were disposed of as medical waste at the facility.

• Brand Name: INTRATHECAL CATHETER
• Type of Device: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; drive 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 11449665
• MDR Text Key: 248076253
• Report Number: 3010079947-2021-00077
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)171015(10)21223
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2017
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 21223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention