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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-3.0-65-REDO
Device Problem Material Puncture/Hole (1504)
Patient Problem Unspecified Infection (1930)
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative
Additional information: patient information - the patient (b)(6) years of age weighing (b)(6) kg. Device return: some part(s) of the device will be returned for evaluation. 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 redo single lumen tpn catheter set was used to repair a cook catheter delivering tpn and iron infusions. The cook catheter was said to have "popped" on (b)(6) 2018 during a saline flush, which caused a hole. The line was locked with heparin and a culture was taken. The culture tested positive for infection and antibiotic treatment was given. As reported, the patient did not require an additional procedure to replace the line as the line was repaired with the repair kit.
 
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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 Key8192167
MDR Text Key131338646
Report Number1820334-2018-03714
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
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/20/2021
Device Catalogue NumberC-TPNS-3.0-65-REDO
Device Lot Number9005428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2018
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: 12/21/2018 Patient Sequence Number: 1
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