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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number PICDS-701-MPIS
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Code Available (3191)
Event Date 05/29/2015
Event Type  Injury  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported the nurses discovered a pin prick hole in the catheter near the clamp on the yellow lumen side. It was inserted the day before and they noticed a leak during treatment then it became blocked. As a result, the device was removed and replaced the next day.
 
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Brand NameDOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS 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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6895164
MDR Text Key87447135
Report Number1820334-2017-03308
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPICDS-701-MPIS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2015
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: 09/26/2017 Patient Sequence Number: 1
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