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

Model Number	11823
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/03/2022
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 catheter kit and sub assembly, verification of all final testing performed by/on the catheter kit and sub assembly, verification of sterilization, and packaging for subject catheter kit and sub assembly was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit and sub assembly function.Device was discarded and was not returned for additional evaluation and investigation.As additional physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.Internal complaint number: (b)(4).
Event or Problem Description
Patient tracking received a tracking form reporting a catheter revision.The reason for revision was reported to be a loss of pain therapy.A cap procedure was stated to have been performed in which the catheter was unable to be aspirated.Device was discarded.

• 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: 16183593
• Report Number: 3010079947-2023-00009
• Device Sequence Number: 2661459
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)230212(10)27569
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/09/2023

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: 02/12/2023
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27569
• 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: 01/09/2023
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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