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

Model Number	11823
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Agent contacted technical solutions to report a volume discrepancy.Agent stated that a week before, the patient came for a refill and the full 20 mls were pulled out of their pump.The patient had recently reported an increase in pain and had not undergone any mris.A cap study was performed which showed the catheter to be patent, but tip had reportedly migrated from t10 to t1-t2.Agent reported that csf was easily pulled from the cap during the cap study.After the dye was injected, a priming bolus was not run in order to visualize the dye being primed through the catheter.Later communication with the agent confirmed that the physician believed that there might be an issue with the pump as the catheter was "fine".Agent also stated that the patient's volume was checked the week before, and the volume was observed to be correct.The agent confirmed that revision is not scheduled at this time.
Additional 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 remains implanted and was not returned.Per the instructions for use of the device, catheter migration is a known possible risk of use of the device.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: complaint-(b)(4).

• Brand Name: INTRATHECAL CATHETER
• Common Device Name: 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: 16194203
• Report Number: 3010079947-2023-00008
• Device Sequence Number: 17214777
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)240422(10)F04282201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2024
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: F04282201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male