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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC STOPCOCK; KGZ ACCESSORIES, CATHETER
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COOK INC THREE-WAY PLASTIC STOPCOCK; KGZ ACCESSORIES, CATHETER Back to Search Results
Catalog Number PTWS-2FLL-MLL-R
Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that during preparation for the procedure, the solution sprayed out of the device while it was being flushed.There were no patient injuries or additional procedures.
 
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Brand Name
THREE-WAY PLASTIC STOPCOCK
Type of Device
KGZ ACCESSORIES, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7477224
MDR Text Key107502547
Report Number1820334-2018-01347
Device Sequence Number1
Product Code KGZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberPTWS-2FLL-MLL-R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/30/2018
Initial Date FDA Received05/01/2018
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 N
Patient Sequence Number1
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