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

Catalog Number ST15LN55NSB163N

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2016

Event Type  malfunction  

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 home care patient that the device was in use with patient.According to reporter, the cuff leaked.No adverse effects reported.

Manufacturer Narrative

The reported 5.5mm i.D.Fixed tts" tracheostomy tube was returned for investigation, the device was returned with another tracheostomy tube.A review of the device history record, relevant to the reported lot, found that the device manufactured to specification and passed the quality insurance inspection with no defects being identified.Visual inspection of the returned device was performed by using the unaided eye under normal lighting and damage was observed on the inflation balloon.During inspection, gouges were observed on the section of the balloon where the valve is inserted.Additionally, it was noted that the inflation balloon had 1mm cuts on either side.Functional testing was performed by inflating the device balloon; however, the balloon was unable to inflate.Investigation found that the reported cuts were caused by damage incurred during use.(b)(4).

• Brand Name: BIVONA CUSTOMIZED 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: 5685978
• MDR Text Key: 46126537
• Report Number: 2183502-2016-01106
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• 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: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/2020
• Device Catalogue Number: ST15LN55NSB163N
• Device Lot Number: GS020026
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2005
• 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