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

Model Number 11823

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/19/2022

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 for additional evaluation and investigation.Clinical specialist (cs) reported that the cause of the issue was unknown.Per the instructions for use of the device, catheter fracture is a known possible risk of use of the device.Internal complaint number: (b)(4).

Event Description

Report was received that catheter was replaced.Clinical specialist (cs) reported that the patient was not receiving pain relief, and that a catheter dye study showed a fractured catheter.It was reported that the patient's activity did not change, and the cause of the fracture was unknown.The fractured catheter was clamped and left in the patient.The catheter was not returned.

• 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: 13484768
• MDR Text Key: 285459441
• Report Number: 3010079947-2022-00019
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)211011(10)25932
• 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
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 25932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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