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 08/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Representative reported that a physician performed a dye study on a patient and observed that the catheter had two leaks in it at l2 and l4-5.The catheter was not getting any pain relief.The catheter was later replaced.

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 sections of catheter were returned.The first section was 39.37 cm long with the distal end.There was a barb connection at 36.2 cm from the distal tip.The second section was 36.2 cm long, with no distal end.The sections were found to be patent with air and swi.No leaks were observed in either section of catheter, and the complaint could not be confirmed.It is possible that the catheter was cut at the observed leak, but that cannot be determined from the returned sections of catheter or the information in the complaint.Per the instructions for use of the device, catheter leakage is a known possible risk of use of the device.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: 12525999
• MDR Text Key: 273112186
• Report Number: 3010079947-2021-00269
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)221113(10)27243
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2020
• 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