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

Model Number	11830
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional 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 revision kit, verification of sterilization, and packaging for subject us catheter revision kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter revision kit function.Device was discarded and not returned for additional evaluation and investigation.As additional investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.Per the instructions for use of the device, seroma and catheter tears/breaks are known possible risks of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Patient tracking received a tracking form through email reporting a catheter revision.The reason for revision was confirmed to be a tear in the catheter.Additional communication with the representative covering the issue confirmed that there was a seroma at the incision site which led the physician to replace the catheter.

• 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: 16119053
• Report Number: 3010079947-2023-00003
• Device Sequence Number: 12179256
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)210416(10)25293
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2021
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 25293
• 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: 12/19/2022
• Initial Report FDA Received Date: 01/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female