MAUDE Adverse Event Report: COOK INCORPORATED DAWSON MUELLER; CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY

Model Number G09706

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

The drainage catheter hub would not lock onto the inner dilator/stiffener.

• Brand Name: DAWSON MUELLER
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13884834
• MDR Text Key: 287796979
• Report Number: 13884834
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2022

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 Model Number: G09706
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: 14231263
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other