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

Model Number 11823

Device Problem Leak/Splash (1354)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Seroma (2069)

Event Date 07/28/2020

Event Type  Injury  

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.The catheter was discarded and not returned for additional evaluation and investigation.The physician suspected that the leak was partially contained by the pressure gradient caused by the seroma but no observations were made about the leak itself.Per the instructions for use of the device, catheter leak is a known possible risk of use of the device.(b)(4).

Event Description

Representative reported a patient with a seroma at the catheter site caused by a catheter leak.A cap study was performed that confirmed a leak in the catheter.Representative stated that the patient had a seroma at the catheter site that was drained a few minutes prior to the cap study.Representative reported that when the physician pushed the dye through the cap the seroma immediately filled back up.The physician viewed the seroma under fluoro and saw that the seroma had filled with the dye pushed through the cap.The physician drained 8mls of dye from the seroma after the cap study.It was later stated that collection of csf was observed just before a previous cap study.A catheter revision was later performed, and the segment of catheter was discarded at the facility.

• 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: 11544496
• MDR Text Key: 241544809
• Report Number: 3010079947-2021-00085
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)210601(10)25465
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 25465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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