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

Model Number G10435

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 11/26/2021

Event Type  malfunction  

Event Description

During the prep of the drainage catheter, the metal stiffener became stuck inside the catheter.The catheter was removed and replaced with no harm to the patient.

• 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: 13168008
• MDR Text Key: 283245348
• Report Number: 13168008
• 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: 12/27/2021

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: G10435
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Device Lot Number: 13978414
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other