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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 03/31/2021
Event Type  Injury  
Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit and sub assembly, verification of all final testing performed by/on the catheter kit and sub assembly, verification of sterilization, and packaging for subject catheter kit and sub assembly was performed. The review did not identify any non-conformances, issues or capas associated with catheter kit and sub assembly function. Device remains implanted and will not be returned for additional evaluation and investigation. As the dye study during the revision determined that the catheter was patent and functioning, and additional investigation will not be performed, a definitive root cause for the alleged issue could not be determined. Internal complaint number: (b)(4).
 
Event Description
Reporter stated that the patient was having a lack of pain relief. A cap study was performed in which the doctor was unable to aspirate the catheter. As a result of this, the doctor decided to perform a catheter revision. Upon opening the pump pocket site and again trying to aspirate the catheter they were able to withdraw the medication and subsequently did a dye study and was able to trace and confirm that the catheter was patent and working correctly. The catheter remained implanted.
 
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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 Key11740103
MDR Text Key248239813
Report Number3010079947-2021-00121
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
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/22/2015
Device Model Number11823
Device Catalogue Number11823
Device Lot Number20375
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 Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2013
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: 04/28/2021 Patient Sequence Number: 1
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