MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADULT MID-RANGE AIRE-CUF ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY TU; TRACHEOSTOMY TUBE

Catalog Number 75HA80

Device Problem Air Leak (1008)

Patient Problem Extubate (2402)

Event Date 03/26/2015

Event Type  Injury  

Event Description

User facility reported that the device was in place for approximately 2 hours and the cuff deflated.According to reporter, an emergency tracheostomy tube change was required.No permanent adverse effects reported.

Manufacturer Narrative

Smiths med has received the sample device.A full eval is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths med will file a follow-up report detailing the results of the eval once it is completed.

• Brand Name: BIVONA ADULT MID-RANGE AIRE-CUF ADJUSTABLE NECK FLANGE HYPERFLEX TRACHEOSTOMY TU
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4774936
• MDR Text Key: 5800346
• Report Number: 2183502-2015-00330
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/08/2015

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
• Device Expiration Date: 04/28/2017
• Device Catalogue Number: 75HA80
• Device Lot Number: 2184239
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2015
• Distributor Facility Aware Date: 03/26/2015
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2012
• 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