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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC RING BILIARY DUCT DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
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COOK INC RING BILIARY DUCT DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY Back to Search Results
Model Number G12371
Device Problems Break (1069); Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Date 03/16/2015
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
The nurse discovered that the device was damaged at the distal tip upon opening the device package.It was further noted that the tip of the device was partially broken off.Another device was opened for this case.
 
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Brand Name
RING BILIARY DUCT DRAINAGE CATHETER
Type of Device
GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7014142
MDR Text Key92747362
Report Number1820334-2017-03817
Device Sequence Number1
Product Code GCA
UDI-Device Identifier00827002123717
UDI-Public(01)00827002123717(17)170811(10)5198075
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG12371
Device Catalogue NumberP8.3G-38-40-NP-20S-RING
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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