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U.S. Department of Health and Human Services

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

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FLOWONIX MEDICAL, INC. INTRATHECAL CATHETER Back to Search Results
Model Number 11823
Device Problem No Flow (2991)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
Pending follow up information on the patient status and catheter disposition if explanted. A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of all final testing performed by/on the catheter kit, and packaging for subject catheter kit was performed. The review did not identify any non-conformances, issues or capas associated with catheter kit function. Internal complaint number: (b)(4).
 
Event Description
A patient contacted technical solutions to report that they have not had any pain relief since implantation in 2019. Per follow-up with agent, they reported that a cap study was performed and the physician was unable to aspirate from the cap. Agent also reported that the physician had a difficult time accessing the cap and they were unsure if the physician entered the cap during this procedure. It was reported that the patient had "a lot of hardware in the spine, so it was difficult to obtain a good image and perform a dye study. " due to the patient's age, the physician does not want to perform an explant if not needed. The plan is to shut the pump off for about 72 hours and see if the patient has an increase in pain. This will help assess whether the pump is working or not. Physician has also ordered an x-ray. Patient most likely will have a catheter revision, but surgery has not yet been scheduled.
 
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Brand NameINTRATHECAL CATHETER
Type of DeviceINTRATHECAL 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 Key11792427
MDR Text Key251343340
Report Number3010079947-2021-00132
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2021
Device Model Number11823
Device Catalogue Number11823
Device Lot Number25078
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 Received06/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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