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

Model Number 11823

Device Problem Obstruction of Flow (2423)

Patient Problems Diarrhea (1811); Nausea (1970); Chills (2191); Inadequate Pain Relief (2388); Shaking/Tremors (2515)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

Pending additional follow up information.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.Internal complaint number: (b)(4).

Event Description

Information was received that reported a catheter replacement due to lack of flow through the catheter.The patient had complained of withdrawal symptoms, specifically shaking, chills, nausea and diarrhea in addition to increased pain.It was stated that a dye study was performed.During the replacement surgery, the physician could not detect any areas of abnormality on the catheter itself but there was no leaking of csf after catheter removal.The cause of the issue was determined to be unknown, and the replaced catheter was discarded.

Manufacturer Narrative

Device was discarded and not returned.Although the exact cause could not be established, the instructions for use for the device addresses risks associated with the catheter that may be related to the alleged lack of flow through the catheter.Internal complaint number: (b)(4).

Event Description

Additional information was provided stating that the dye study revealed that there was clearly an abnormality with the catheter because the physician could not aspirate any clear fluid despite unquestionable access to the catheter access port.

• 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 ; 8734269229
• MDR Report Key: 13893046
• MDR Text Key: 287849933
• Report Number: 3010079947-2022-00048
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)210201(10)25069
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 25069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female