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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET DQY CATHETER, PERCUTANEOUS

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COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number C-UTLM-701J
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Pma/510(k) #: k081113. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

It was reported a triple lumen polyurethane central venous catheter set was used during a research study to retrieve cerebral venous blood samples. The line was in place for approximately 5 hours and samples were taken every 5-10 minutes. The line was flushed frequently with saline after samples were taken. Significant clots within the internal jugular vein were observed and measured via duplex ultrasound. The progression of these clots were tracked and said to dissipate. As reported, the issue of clotting was not noted when different catheters were used. The patient did not experience any adverse effects or require any additional procedures due to this occurrence.

 
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Brand NameTRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
Type of DeviceDQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7660214
MDR Text Key113189515
Report Number1820334-2018-01999
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK081113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberC-UTLM-701J
Device LOT Number8557094
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2018
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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