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

Model Number	11830
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Discomfort (2330); Inadequate Pain Relief (2388)
Date of Event	08/05/2021
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, 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.Per the instructions for use of the device, catheter occlusion is a known possible risk of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) reported that the patient had been complaining of increased pain and withdrawal-like symptoms.Cs reported that the patient had a catheter dye study performed and it was noted that the catheter was likely occluded and required replacement.It was also reported that there had been a gradual increase in reservoir volume over the past three refills.The pump and catheter were replaced and were discarded.The reporter was not informed of anything noted at the replacement surgery.Mdr 3010079947-2022-00012 was opened to address the pump issues.

• 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: 13497717
• Report Number: 3010079947-2022-00023
• Device Sequence Number: 4253148
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)210726(10)25656
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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): 01/26/2022

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: 07/26/2021
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 25656
• 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: 01/26/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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