MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, BILIARY, SURGICAL

Model Number G06083

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 12/10/2018

Event Type  malfunction  

Event Description

Interventional radiology department staff reported that there have been problems recently with many of our drains and stylets getting stuck.So much so, that it starts to accordion and snap.It seems to only be with the blue plastic stylets.This has happened several times recently to two different physicians.This problem was reported to cook medical district manager on (b)(6) 2018.We have one to give to cook for investigation and the district manager will pick it up this week.

• Brand Name: COOK
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8270221
• MDR Text Key: 133852145
• Report Number: 8270221
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G06083
• Device Catalogue Number: ULT8.5-38-40-P-32S-BCL
• Device Lot Number: 6817417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1