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

Model Number 11823

Device Problem Leak/Splash (1354)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Clinical specialist (cs) contacted technical solutions to report a catheter revision.Cs reported that csf had accumulated around the pump pocket.Cs reported that the patient was asymptomatic but a small section of the catheter close to the pump had eroded or wore thin and caused the leak.Device was returned.

Manufacturer Narrative

Pending completion of device analysis.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, verification of sterilization, 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.Internal complaint number: complaint-(b)(4).

Manufacturer Narrative

Device was returned for additional evaluation and investigation.One section of catheter that was returned was 4 cm long with no distal end.A cut was observed close to one end of this section.The cut leaked when sterile water was pushed through the section of catheter.The second section of catheter was 1cm long.It had no distal end.One end of this section of catheter was tattered.Both sections of catheter were patent with air and sterile water for injection (swi).Engineering was unable to determine the cause for either cut or the tattered end on the sections of catheter from the analysis or from the information in the complaint.Internal complaint number: (b)(4).

• Brand Name: INTRATHECAL CATHETER
• Type of Device: 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: 13255585
• MDR Text Key: 285338737
• Report Number: 3010079947-2022-00007
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)210308(10)25184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 25184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female