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

Model Number 11823

Device Problem No Flow (2991)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

Pending follow up information on the patient status and catheter disposition if explanted. A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of all final testing performed by/on the catheter kit, and packaging for subject catheter kit was performed. The review did not identify any non-conformances, issues or capas associated with catheter kit function. Internal complaint number: (b)(4).

Event Description

A patient contacted technical solutions to report that they have not had any pain relief since implantation in 2019. Per follow-up with agent, they reported that a cap study was performed and the physician was unable to aspirate from the cap. Agent also reported that the physician had a difficult time accessing the cap and they were unsure if the physician entered the cap during this procedure. It was reported that the patient had "a lot of hardware in the spine, so it was difficult to obtain a good image and perform a dye study. " due to the patient's age, the physician does not want to perform an explant if not needed. The plan is to shut the pump off for about 72 hours and see if the patient has an increase in pain. This will help assess whether the pump is working or not. Physician has also ordered an x-ray. Patient most likely will have a catheter revision, but surgery has not yet been scheduled.

• 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; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 11792427
• MDR Text Key: 251343340
• Report Number: 3010079947-2021-00132
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/01/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 25078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial