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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN SILICONE CENTRAL VENOUS/HYPERALIMENTATION CATHETER SET

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COOK INC TRIPLE LUMEN SILICONE CENTRAL VENOUS/HYPERALIMENTATION CATHETER SET Back to Search Results
Catalog Number C-HASTC-1250J-CANADA
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol_cap(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
The catheter was inserted. Blood was being drawn from the red cvc lumen when a pinhole was noted. Blood started leaking from the hole, but there was no harm to the patient. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameTRIPLE LUMEN SILICONE CENTRAL VENOUS/HYPERALIMENTATION CATHETER SET
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6893394
MDR Text Key89470998
Report Number1820334-2017-03332
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-HASTC-1250J-CANADA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2015
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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