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 03/31/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit and sub assembly, verification of all final testing performed by/on the catheter kit and sub assembly, verification of sterilization, and packaging for subject catheter kit and sub assembly was performed. The review did not identify any non-conformances, issues or capas associated with catheter kit and sub assembly function. Device remains implanted and will not be returned for additional evaluation and investigation. As the dye study during the revision determined that the catheter was patent and functioning, and additional investigation will not be performed, a definitive root cause for the alleged issue could not be determined. Internal complaint number: (b)(4).

Event Description

Reporter stated that the patient was having a lack of pain relief. A cap study was performed in which the doctor was unable to aspirate the catheter. As a result of this, the doctor decided to perform a catheter revision. Upon opening the pump pocket site and again trying to aspirate the catheter they were able to withdraw the medication and subsequently did a dye study and was able to trace and confirm that the catheter was patent and working correctly. The catheter remained implanted.

• 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: 11740103
• MDR Text Key: 248239813
• Report Number: 3010079947-2021-00121
• 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
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/22/2015
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 20375
• 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: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/28/2021 Patient Sequence Number: 1