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

Model Number 11823

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  Injury  

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 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.Internal complaint number: (b)(4).

Event Description

Representative reported that an issue was observed during surgery: "tuohy needle was inserted into the intrathecal space with no issue.Csf flowed back through the needle.When the catheter was advanced through the needle a few inches it would not advance any further nor could it be pulled back out.It seemed to somehow be stuck inside the needle.A new needle and was inserted into the intrathecal space and a new catheter was advanced with no issue.The old catheter and tuohy needle were pulled out together.After removal from the intrathecal space it still seemed to be wedged into the needle and required a force more than normal to dislodge from the tuohy needle." additional communication with representative confirmed that the surgery took about 30-45 minutes longer than usual.

Manufacturer Narrative

Device was returned for additional evaluation and investigation.Engineering was able to advance the catheter through the needle and pull it out of the needle completely without issue.This was done prior to decontamination of the product to make sure the decontamination process did not affect the outcome of the testing.The root cause for the complaint could not be determined as the catheter was able to move freely through the tuohy needle during the analysis.No issue was found with these products.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: 13980242
• MDR Text Key: 289187042
• Report Number: 3010079947-2022-00056
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)230524(10)27949
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2023
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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): Other
• Patient Sex: Female