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

Model Number 11823

Device Problems Material Puncture/Hole (1504); Insufficient Flow or Under Infusion (2182)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/02/2022

Event Type  Injury  

Event Description

Information was received reporting a pump and catheter replacement.The reason for the replacement was reported to be that the patient was not receiving pain relief, multiple volume discrepancies were observed, and the catheter was found to have a small leak during a dye study.

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, 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: (b)(4).

Manufacturer Narrative

Corrected information: h3, h6 device was returned for additional evaluation and investigation.A 53.34 cm section of catheter was returned.The non-distal end was not patent with air and swi.A leak was observed at one end of the catheter.This was determined to be the likely cause for the issue observed.Per the instructions of use of the device, catheter leakage is a known possible risk of use of the device.Internal complaint number: complaint, (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: 15337060
• MDR Text Key: 299077248
• Report Number: 3010079947-2022-00157
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)240524(10)28707
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 28707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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