MAUDE Adverse Event Report: COOK, INC.; CATHETER, BILIARY, SURGICAL

Model Number G11956

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2017

Event Type  malfunction  

Event Description

A patient presented for biliary catheter check and exchange.She had a cook ring biliary 10 french catheter placed and was discharged home.One week later it was discovered that the plastic stiffener had not been removed.The cap to the plastic stiffener and the cap to the catheter are both white.The stiffener on the inside is blue, but that is only useful when removing the stiffener and not when it is visualized from the outside.

• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6954582
• MDR Text Key: 89495807
• Report Number: 6954582
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2017

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
• Device Operator: No Information
• Device Model Number: G11956
• Device Catalogue Number: ULT10.2-38-50-P-RING-25.5-MEH
• Other Device ID Number: BILIARY DRAIN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NOT APPLICABLE.
• Patient Age: 52 YR