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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 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.
 
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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 Key11925063
MDR Text Key261717882
Report Number3010079947-2021-00150
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 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11823
Device Catalogue Number11823
Device Lot Number26908
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 Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2020
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
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