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

Model Number 11823

Device Problem Leak/Splash (1354)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of sterilization, and packaging for subject catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit.Device was discarded and not returned for additional evaluation and investigation.Clinical specialist (cs) stated that the catheter leak may be due to the patient's anatomy or stenosis, but the causality was unable to be confirmed.Per the instructions for use of the device, catheter leak is a known possible risk of use of the device.Internal complaint number: (b)(4).

Event Description

Patient tracking received a patient tracking form through email reporting a catheter revision due to a small leak at the spinal incision.Device was discarded.Additional follow up with the clinical specialist (cs) covering this issue confirmed that the patient had a catheter leak which was identified on a ct scan.The patient had presented with a decrease in therapy two months prior and there was a slight volume discrepancy observed as well.The physician had reportedly supplemented the patient with oral medication at that time.In regard to causality, cs stated that the patient admitted to a "huge fall" at one point, but this was on their front side near the pump, not on their back near the catheter.Cs additionally stated that the catheter leak may be due to the patient's anatomy or stenosis, but causality was unable to be confirmed.

• 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: 15494242
• MDR Text Key: 300759153
• Report Number: 3010079947-2022-00180
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)200112(10)23963
• 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
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 23963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• 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