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

Model Number G10047

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2016

Event Type  malfunction  

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

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
• 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 Key: 7034368
• MDR Text Key: 93078774
• Report Number: 1820334-2017-04087
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002100473
• UDI-Public: (01)00827002100473(17)181210(10)NS6318460
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G10047
• Device Catalogue Number: CLB-10.2-RH-NPAS-NT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1