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

Model Number 11823

Device Problems Insufficient Flow or Under Infusion (2182); Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/22/2021

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. Device was discarded and not returned for additional evaluation and investigation. Per the instructions for use of the device, catheter disconnection is a known possible risk of use of the device. Internal complaint number: (b)(4).

Event Description

Sales representative contacted technical solutions via email to report an underinfusion volume discrepancy. The expected volume was 8ml and the actual aspirated volume was 26ml. The patient reported a loss of pain relief. A dye study was performed, which confirmed that the catheter became disconnected from the pump. A catheter revision was performed which replaced the old catheter, which was then discarded.

• 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: 11925063
• MDR Text Key: 261717882
• Report Number: 3010079947-2021-00150
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 26908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/02/2021 Patient Sequence Number: 1