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

Model Number	G55652
Health Effect - Clinical Codes	Hypoventilation (1916); No Code Available (3191)
Date of Event	03/04/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7370035
• Report Number: 1820334-2018-00883
• Device Sequence Number: 69542
• Product Code: BTO
• UDI-Device Identifier: 00827002556522
• UDI-Public: (01)00827002556522(17)170817(10)5201216
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G55652
• Device Catalogue Number: C-VT-9
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention