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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN TPN CATHETER FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC COOK TPN SINGLE LUMEN TPN CATHETER FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number C-TPN-3.0-55
Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2013
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that the area of the picc line where the luer attaches to the line was loose and twisted around. It was also reported that when flushed, the luer blew off. There were no issues with the repair of the line.
 
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Brand NameCOOK TPN SINGLE LUMEN TPN CATHETER
Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6887817
MDR Text Key87377980
Report Number1820334-2017-03303
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-TPN-3.0-55
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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 Manufactured07/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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