MAUDE Adverse Event Report: COOK COOK; CATHETER

Model Number G09501

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/24/2017

Event Type  malfunction  

Event Description

The hub connected to the catheter attached to patient's right side came off.Diagnosis or reason for use: nephrostomy tube.Cook g09501 - 8.5f multipurpose.

• Brand Name: COOK
• Type of Device: CATHETER
• Manufacturer (Section D): COOK
• MDR Report Key: 6989988
• MDR Text Key: 90754241
• Report Number: MW5073049
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G09501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 59