MAUDE Adverse Event Report: COOK INCORPORATED DAWSON-MUELLER DRAINAGE CATHETER; CATHETER, NEPHROSTOMY

Model Number G09706

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Patient having a percutaneous cholecystostomy tube placed.The trocar metal stylet would not screw into the catheter appropriately.Manufacturer response for drainage catheter, cook dawson-mueller drainage catheter (per site reporter) representative.

• Brand Name: DAWSON-MUELLER DRAINAGE CATHETER
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 15787558
• MDR Text Key: 303542220
• Report Number: 15787558
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022,11/03/2022

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 Operator: Health Professional
• Device Model Number: G09706
• Device Catalogue Number: G09706
• Device Lot Number: 14798037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31755 DA
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Race: White