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

Model Number 11823

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 03/06/2022

Event Type  Injury  

Event Description

Agent contacted technical solutions about a patient who was experiencing severe pain and nausea.Agent reported that the patient started experiencing symptoms 10 days ago.Agent reported that the patient has had no falls and an mri.No significant volume discrepancies were noted.Agent reported no error codes and reports no cap studies or troubleshooting was considered.Pump and catheter was explanted and replaced with a medtronic kit at the direction of the managing physician.This mdr will address the catheter issue and explant.Mdr 3010079947-2022-00060 will address the pump issue and explant.

Manufacturer Narrative

Pending completion of device analysis and review of device history record.Internal complaint number: (b)(4).

Manufacturer Narrative

Device was returned for additional evaluation and investigation.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.Additional physical investigation was performed on the device, but the alleged issue could not be confirmed.Two pieces of the catheter were returned, one section was 35.56 cm with a distal end, and a second section that was 50.8 cm with no distal end, had an analysis performed.The analysis confirmed that both sections were patent with air and swi.The root cause for the complaint was determined to be unrelated to the catheter.The root cause of the alleged issue was determined to be related to the patient's pump, and that investigation conclusion was captured through mfr 3010079947-2022-00060-01.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: 14117760
• MDR Text Key: 289326751
• Report Number: 3010079947-2022-00061
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)200209(10)24256
• 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: 03/16/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2020
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 24256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• 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
• Patient Sex: Female