MAUDE Adverse Event Report: SMITHS MEDICAL, INC. BIVONA CUSTOMER TTS FLEXTEND TRACHEOSTOMY TUBE; JOH - TRACHEOSTOMY TUBE

Catalog Number FT14BN50NGF170N

Device Problem Cut In Material (2454)

Patient Problem Extubate (2402)

Event Type  Injury  

Event Description

A report was received that a tracheostomy tube flange split while in use with a patient after an unknown amount of time.An emergent tracheostomy tube exchange was required.No permanent adverse effects to patient reported.

Manufacturer Narrative

The following is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

• Brand Name: BIVONA CUSTOMER TTS FLEXTEND TRACHEOSTOMY TUBE
• Type of Device: JOH - TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: pete hirte ; 1265 grey fox road; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3901010
• MDR Text Key: 4671749
• Report Number: 2183502-2014-00409
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/16/2014

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
• Device Expiration Date: 02/26/2019
• Device Catalogue Number: FT14BN50NGF170N
• Device Lot Number: CS011521
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: No
• Date Report Sent to FDA: 06/16/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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): Required Intervention