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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 Problems Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: currently unknown, but was noted to have occurred within the last week on (b)(6) 2019. Occupation: director of product discovery. Brand name: device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray 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 cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray was used during placement of a femoral line. As reported, the wire moved through the needle and the catheter without difficulty. Upon removal of the wire, the wire became stuck in the catheter and the provider had to use force to remove causing the ¿wire stretched and bent at the tip¿. The report indicates no section of the device remains in patient. Additional information regarding the event details has been requested but is currently unavailable. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8445732
MDR Text Key139726801
Report Number1820334-2019-00687
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-UDLMY-801J-ABRM-CUSTOM-0049
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 Received05/17/2019
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

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