MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE - BIVONA TUBES ADULT TTS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 670170

Device Problem Burst Container or Vessel (1074)

Patient Problem Airway Obstruction (1699)

Event Date 04/23/2021

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical trach burst while in use.A new trach was inserted and that one burst later that same day.There was nothing remarkable about the patient's anatomy.The patient has easy removals and insertions and has been using bivona for at least 6 month without issue.There were no other reported adverse events.

Manufacturer Narrative

Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

Other text: additional information h6.This remediation mdr was generated under protocol: (b)(4), as a result of warning letter cms#: 617147.

• Brand Name: SILICONE - BIVONA TUBES ADULT TTS
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11873567
• MDR Text Key: 252308201
• Report Number: 3012307300-2021-04925
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: 15021312006056
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 670170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• 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): Life Threatening; Required Intervention