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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  Injury  
Manufacturer Narrative
Pending completion of device analysis and review of device history record. Internal complaint number: (b)(4).
 
Event Description
Agent contacted technical solutions via email to report a catheter that was replaced at implant due to the physician being unable to confirm csf flow. Agent reported: "during physician's final check at the last stage of the surgery, [they] aspirated from the catheter access port and did not get csf. Csf was verified earlier in the surgery during placement of the tuohy needle. Catheter was fully connected to the pump/stem. After disconnecting, physician also tried aspirating from the catheter which [they] also did not get csf. [they] trimmed the catheter a few times and aspirated again, still no csf. So we removed the remaining part of the catheter, placed a new one and it worked without any problems. " agent confirmed that the surgery was delayed 30 minutes and there was no visual defects observed.
 
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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 Key11961917
MDR Text Key260064138
Report Number3010079947-2021-00166
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 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11823
Device Catalogue Number11823
Device Lot Number27318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/11/2020
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: 06/08/2021 Patient Sequence Number: 1
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