MAUDE Adverse Event Report: COOK, INC. VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number G54919

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2018

Event Type  Injury  

Event Description

Patient's tracheostomy has broken.Eight shiley tracheostomy was removed after a cook catheter been placed into the trachea and a replacement #8 shiley tracheostomy tube was passed into his trachea limb.Bleeding at site after trach exchange and hemoptysis worse.Pt required fio2 increase from 28 to 40%.

• Brand Name: VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CA
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7946301
• MDR Text Key: 123063434
• Report Number: 7946301
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G54919
• Device Catalogue Number: C-VTIC-8
• Device Lot Number: 18A0556JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 18980 DA