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

Catalog Number FT12HN55NSF003N

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating that the eyelet on the flange of a tracheostomy tube split after an unknown amount of time in use.No permanent adverse effects to patient reported.

Manufacturer Narrative

(b)(4).Customer has not yet returned the device to the manufacturer 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 CUSTOM 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 rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4081052
• MDR Text Key: 4827242
• Report Number: 2183502-2014-00625
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/25/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2018
• Device Catalogue Number: FT12HN55NSF003N
• Device Lot Number: CS012769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2014
• Device Age: 17 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/07/2014
• Initial Date FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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