MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOMIZED FLEXTEND TRACHEOSTOMY TUBE

Catalog Number FT16AN65NSC064N

Device Problem Air Leak (1008)

Patient Problem Respiratory Distress (2045)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Patient's nurse reported that the device was in use with patient.According to reporter, after 2.5 hours in use, the patient's heart rate increased.Upon examination the nurse determined the device cuff was leaking.Patient's caregiver reported that an emergency tracheostomy tube change was performed to address the issue.No permanent adverse effects reported.

• Brand Name: BIVONA CUSTOMIZED FLEXTEND TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 w 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5672244
• MDR Text Key: 45683232
• Report Number: 2183502-2016-01061
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: FT16AN65NSC064N
• Device Lot Number: GS023321
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2016
• 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