MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TTS ADULT TRACHEOSTOMY TUBE; BIVONA TRACHEOSTOMY TUBE

Catalog Number 670170

Device Problem Air Leak (1008)

Patient Problem Respiratory Distress (2045)

Event Date 04/19/2016

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

Distributor reported on behalf of the user facility that the device was in use with patient for approximately 20 hours.The hospital staff noted cuff leakage and an emergency tube change was required to address the issue.No permanent adverse effects reported.

Manufacturer Narrative

One used tracheostomy tube was returned for evaluation.Visual inspection found the device to be in a used condition.During functional testing, a syringe was used to inflate the device cuff with 7 cc of air; the cuff inflated and deflated very quickly.The cuff was then re-inflated with 7 cc of air and the entire device was submerged in water.Bubbles (indicating a leak) were observed escaping from the cuff of the device.The cuff was found to have cut/scratches in two different areas.A review of the device history records showed no non-conformities in the manufacturing process.Additionally, manufacturing performs a 100% inspection on all devices prior to being packaged.Therefore, the cuff is believed to have become damaged during device use.No evidence was found to suggest the reported event was caused from an intrinsic product problem.Additional information included in follow-up report: device return date (05/09/2016).Device evaluation completed (07/19/2016).

• Brand Name: BIVONA TTS ADULT TRACHEOSTOMY TUBE
• Type of Device: BIVONA TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 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: 5641182
• MDR Text Key: 44739086
• Report Number: 2183502-2016-00916
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/28/2019
• Device Catalogue Number: 670170
• Device Lot Number: 2700212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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