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U.S. Department of Health and Human Services

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

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COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Code Available (3191)
Event Date 04/21/2020
Event Type  Injury  
Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray reporter occupation: clinic administrator. (b)(4). 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 that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was found to be split on the side wall upon removal from the patient. The indication for placement of the catheter was for medication administration. The catheter was implanted on (b)(6) 2020 in the left internal jugular. The device was sutured to the bedridden patient and secured with a dressing. The procedure being performed at the time of failure was iv medication administration with a pump from another manufacturer. The device separation was partial, as it is still in one piece, and the device was described to be "blown out at about 13cm above the tip". The device was removed on (b)(6) 2020 due to "ports without blood return". The device was no longer necessary, so peripheral ivs were placed. A new triple lumen catheter was placed on (b)(6) 2020. The issue did not prolong the patient's stay in the hospital. No other adverse effects have been reported.
 
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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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10025030
MDR Text Key194476353
Report Number1820334-2020-00907
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-UTLMY-701J-ABRM-CUSTOM-0042
Device Lot NumberUNKNOWN
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 Received06/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/05/2020 Patient Sequence Number: 1
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