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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
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/03/2013
Type of Reportable Event Malfunction
Additional 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 or Problem 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 Name
COOK TPN SINGLE LUMEN TPN CATHETER
Common Device Name
FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6887817
Report Number1820334-2017-03303
Device Sequence Number10921050
Product Code FOZ
UDI-Device Identifier00827002042612
UDI-Public(01)00827002042612(17)160701(10)4391255
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberC-TPN-3.0-55
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2017
Initial Report FDA Received Date09/22/2017
Patient Sequence Number1
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