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

Model Number	11823
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
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 for additional evaluation and investigation.The physician stated that they are unsure as to what caused the catheter breakage.Per the instructions for use of the device, catheter breaks and tears are known possible risks of use of the device.A supplemental mdr will be sent when information regarding scheduled catheter revision is obtained.Internal complaint number: (b)(4).
Event or Problem Description
Agent contacted technical solutions to report a broken catheter that was observed in a catheter dye study.Agent stated that the dye study was done due to a lack of pain relief felt by the patient.The dye study reportedly showed the catheter to be broken near the sacrum and the catheter tip was "close to where they entered the intrathecal space." agent reported that a catheter revision will be done, but this procedure is not scheduled yet.Agent stated that the patient has not had any recent falls or accidents, and the physician is unsure of what caused the breakage.Agent was unaware of the type of medication in the patient's pump or the date on which the patient symptoms started.

• 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: 15995632
• Report Number: 3010079947-2022-00213
• Device Sequence Number: 5672407
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)150430(10)18730
• 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: 2015
• 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): 11/28/2022

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: 04/30/2015
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 18730
• 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: 11/28/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2013
• 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: Female