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

Catalog Number FT16DN60NGC999N

Device Problem Air Leak (1008)

Patient Problem Respiratory Distress (2045)

Event Date 04/25/2016

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 caregiver reported on behalf of home care patient that the device was in use with patient.According to reporter, the cuff leaked during ventilation.Patient's caregiver reported that an emergency tracheostomy tube change was performed to address the issue.No permanent adverse effects reported.

Manufacturer Narrative

The reported customized tracheostomy tube was returned for investigation.The sample was received without its original packaging.During investigation, two potential lots were found for the returned device, ss002128 and ss00217.A device history review was performed on the two possible lots, no manufacturing non-conformities were found.Additionally, based upon a review of the device history files, it was found that the cuff functioned properly prior to shipment.During functional testing, the device cuff was inflated with 12cc of air; however, the cuff did not inflate.Upon examination, it was observed that a section of the adhesive on the distal tip was missing in an area where there should be a smooth bead of adhesive around the entire circumference of the shaft tip.The defect observed in the bond between the cuff band and the shaft at the distal tip of the shaft resulted in a leak.Investigation was unable to determine the root cause of the missing adhesive; however, no evidence was found to suggest a manufacturing defect.Mfr# clarification: new registration number 3012307300 (b)(4) has been received, however, this initial mdr was filed under the prior registration number 2183502 (b)(4).

• 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: 5672224
• MDR Text Key: 45683140
• Report Number: 2183502-2016-01059
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• 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: Patient Family Member or Friend
• Device Catalogue Number: FT16DN60NGC999N
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 18 YR