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

Model Number	11830
Medical Device Problem Codes	Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received reporting a system replacement due to "catheter issues" and the "patient needing a larger pump." several attempts were made to follow up with the agent covering the issue, but no information has been received yet.
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, 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 was not returned for additional evaluation and investigation.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
Follow-up communication was received from the representative covering the issue.Representative stated that the patient had experienced a lack of pain relief due to a suture becoming wrapped around 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: 15854061
• Report Number: 3010079947-2022-00203
• Device Sequence Number: 5226030
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)221120(10)27219
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 11/20/2022
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 27219
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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