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

Model Number 11823

Device Problems Fracture (1260); Insufficient Flow or Under Infusion (2182)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/05/2022

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 revision 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 discarded and not returned for additional evaluation and investigation.The physician reported that the cause of the catheter fracture 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

Information was received that confirmed that a catheter was revised due to volume discrepancies.The patient complained of increased pain at a refill appointment.At the same refill appointment, an underinfusion volume discrepancy was observed, with the expected volume being 3.8ml and the actual aspirated volume being 10ml.During the surgery, the catheter was found to be fractured.The physician did not know the cause of the catheter fracture.The original pump was replaced due to device age.No issues were noted with the pump.Both the original pump and revised catheter segment were discarded.

• 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: 13715333
• MDR Text Key: 287429340
• Report Number: 3010079947-2022-00036
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 19502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• 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
• Patient Sex: Male