MAUDE Adverse Event Report: COOK, INC. WAYNE PNEUMOTHORAX TRAY; CANNULA CATHETER

Model Number C-UTPTY-1400-WAYNE-112497-IMH

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 09/22/2018

Event Type  Injury  

Event Description

A 14.0fr catheter (wayne pneumothorax tray, cook medical, (b)(4), usa) was placed for treatment of pneumothorax.The catheter obturator, a stiffening device used to aid catheter insertion, was not removed as intended following insertion of the catheter.This appropriate device function for drainage of a pneumothorax.The healthcare provider recognized the error within approximately 30 minutes and removed the obturator, restoring device function.The device design facilitates this error, because the obturator unnecessarily includes a connector at its proximal tip, allowing it to be connected to the external drainage system.We have previously reported this problem to fda and the device mfr when the same form of error was committed by different healthcare providers in a different patient.Left unrecognized, this error could be fatal to a patient or could result in the need for additional medical procedures.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Type of Device: CANNULA CATHETER
• Manufacturer (Section D): COOK, INC. ; bloomington IN
• MDR Report Key: 8080096
• MDR Text Key: 128029103
• Report Number: MW5081424
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-UTPTY-1400-WAYNE-112497-IMH
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 5 MO