MAUDE Adverse Event Report: COOK MEDICAL INC MAC-LOC; CATHETER BILIARY SURGICAL

Catalog Number G09501

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 07/07/2015

Event Type  malfunction  

Event Description

Patient was seen for routine biliary tube change.Placed a cook mac-loc 7 fr x 25cm drainage tube with no complications during the procedure.Once discharged, patient reported tube leaking at the connector hub site.Patient came to clinic and tube was confirmed to be defective.Tube changed out for a new one.

• Brand Name: MAC-LOC
• Type of Device: CATHETER BILIARY SURGICAL
• Manufacturer (Section D): COOK MEDICAL INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 4972680
• MDR Text Key: 6075858
• Report Number: 4972680
• Device Sequence Number: 1
• Product Code: GCA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Patient
• Device Catalogue Number: G09501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR