MAUDE Adverse Event Report: COOK INC ULTRATHANE BILIARY DRAINAGE SET; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number	G10047
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During the inspection, it was observed that there was a malfunction to the sterile device packaging., there was a tear in the film packaging.

• Brand Name: ULTRATHANE BILIARY DRAINAGE SET
• Common Device Name: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7034368
• Report Number: 1820334-2017-04087
• Device Sequence Number: 2144230
• Product Code: GCA
• UDI-Device Identifier: 00827002100473
• UDI-Public: (01)00827002100473(17)181210(10)NS6318460
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: No Information
• Device Model Number: G10047
• Device Catalogue Number: CLB-10.2-RH-NPAS-NT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1