MAUDE Adverse Event Report: COOK INC VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE; BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number G55652

Device Problems Leak/Splash (1354); Inaccurate Delivery (2339)

Patient Problems Hypoventilation (1916); No Code Available (3191)

Event Date 03/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that the after the cannula of a versatube¿ tapered tracheostomy tube was inserted, it had an apparent cuff leak and would not allow proper ventilation.Another cannula was placed successfully, but it was found to be delivering insufficient oxygen the following day, so it was replaced with another company¿s device.There were no injuries reported aside from this additional procedure.

• Brand Name: VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE
• Type of Device: BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7370035
• MDR Text Key: 103444867
• Report Number: 1820334-2018-00883
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 00827002556522
• UDI-Public: (01)00827002556522(17)170817(10)5201216
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G55652
• Device Catalogue Number: C-VT-9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention