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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
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/16/2015
Type of Reportable Event Malfunction
Additional 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 or Problem 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
Common Device Name
GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7014142
Report Number1820334-2017-03817
Device Sequence Number2037020
Product Code GCA
UDI-Device Identifier00827002123717
UDI-Public(01)00827002123717(17)170811(10)5198075
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/09/2017
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
Operator of Device Health Professional
Device Model NumberG12371
Device Catalogue NumberP8.3G-38-40-NP-20S-RING
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2017
Initial Report FDA Received Date11/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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