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U.S. Department of Health and Human Services

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

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COOK INC REDO SINGLE LUMEN TPN CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number C-TPNS-4.0-65-REDO
Device Problem Break (1069)
Patient Problem Feeding Problem (1850)
Event Type  Injury  
Manufacturer Narrative
The exact rpn is unknown. It has been reported that the device may be c-tpns-4. 0-65-redo or c-tpns-6. 5-90-redo. (b)(6). Occupation: unknown. 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 initially reported there have been several instances over the past year where tpn catheters, reported as either c-tpns-4. 0-65-redo or c-tpns-6. 5-90-redo have broken down prematurely. It was further reported that there have been cases where the outer lumen is coming away from the inner lumen and of ballooning out and exposing the inner sheath. The reported devices were used predominantly with pediatric patients for total parental nutrition. Five devices were saved to be returned to cook. At this time it was clarified that the outer lumen is separating from inner lumen/fracture breaking approximately 4 inches from hub. When the separation was noted, the patient received another tpn line. The second returned device is the subject of this report. The related mdr reports are: 1820334-2019-00422, 1820334-2019-00424, 1820334-2019-00425, and 1820334-2019-00426.
 
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Brand NameREDO SINGLE LUMEN TPN CATHETER SET
Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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 Key8332794
MDR Text Key135939773
Report Number1820334-2019-00423
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K950118
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-TPNS-4.0-65-REDO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? Yes
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: 02/12/2019 Patient Sequence Number: 1
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