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

Catalog Number 67SP045

Device Problem Air Leak (1008)

Patient Problem Extubate (2402)

Event Date 07/05/2015

Event Type  Injury  

Event Description

It was reported that after an unknown amount of time in situ, cuff was found leaking.Patient is ventilator dependent; therefore required an emergent trach change.No permanent adverse effects to patient.

Manufacturer Narrative

(b)(4).Device evaluation: 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.

Manufacturer Narrative

One used device was returned for evaluation.During functional testing, a syringe was used to inflate the device cuff with 8 cc of air.The device was then submerged in water.Bubbles were observed escaping a small pin hole located on the pilot balloon.Manufacturing performs a 100% leak test prior to product dispersal.Had the hole been present at that time, a leak would have been detected and the device scrapped.The root cause for the hole could not be definitely determined; however, the issue was not identified as being attributed to the manufacturing of the device.

• Brand Name: BIVONA ADULT TTS TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4965365
• MDR Text Key: 6195934
• Report Number: 2183502-2015-00568
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2015

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: Home Health Aide
• Device Expiration Date: 06/28/2019
• Device Catalogue Number: 67SP045
• Device Lot Number: 2737841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2014
• 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