MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. BIVONA CUFFED TRACHEOSTOMY TUBE; JOH-TRACHEOSTOMY TUBE

Device Problem Air Leak (1008)

Patient Problem Extubate (2402)

Event Date 07/20/2014

Event Type  Injury  

Event Description

It was reported that the cuff was observed to be leaking after an unknown amount of time in use.Customer had inflated with air, when this particular tube requires inflation with saline/water.Emergent tracheostomy change was required, however there was no immediate harm to the patient.

Manufacturer Narrative

Customer has not yet returned the device to the manufacture for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: BIVONA CUFFED TRACHEOSTOMY TUBE
• Type of Device: JOH-TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4551453
• MDR Text Key: 20785644
• Report Number: 2183502-2015-00055
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 02/17/2015
• Distributor Facility Aware Date: 07/20/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other