MAUDE Adverse Event Report: ST PAUL BIVONA; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problems Positioning Failure (1158); Dent in Material (2526)

Patient Problem Respiratory Distress (2045)

Event Date 09/16/2020

Event Type  Injury  

Event Description

It was reported that the parents of the patient performed a tracheostomy tube change on wednesday evening as their child was having secretions and increased work of breathing.The patient suffered from laryngomalacia.When performing the change they noticed that the wire rings within the tube had become displaced and that there was a dent in the tube.The parent replaced the affected custom bivona tracheostomy tube.The next morning the patient had to be transferred to the hospital for respiratory issues from a possible viral infection.The patient was discharged 24 hours later and had fully recovered.The custom bivona tracheostomy was used on the patient for 1 week without issue.The product problem was only observed during the week of the incident.

Manufacturer Narrative

Other, other text: investigation completed on a smiths medical tracheostomy|silicone - bivona tube was received and reviewed under visual inspection p/n 60nfps35 l/n unknown.The tube was reviewed to be crushed and wires were misaligned.In attempt to reproduce the complaint, the shaft was twisted and pulled with force in order to see if the complaint could be reproduced.It was seen that in all samples the wire of the shaft was misaligned, and the tube was kinked.This units were like the sample received.See pictures provided.Manufacturing guidelines stated below: on section 4.8 states: do not use a tube that is cur or damaged.Use of a damaged tube can result in airway compromise.This device must be thoroughly inspected for signs of damage or wear prior to each use.See images below for evidence: on section 4.4 states: the security of all connectors should be checked when the circuit is established and frequently thereafter.Failure to do so may result in restricted ventilation.Avoid application of excessive rotation or lineal forces on the tube during and after attachment of the breathing system to the tracheostomy tube to prevent accidental disconnection or occlusion.See images below for evidence: reviewed manufacturing process production line which revealed production line passing at 100% prior to release of product.The occurrence is believed to happen after leaving manufacturing.

Event Description

Investigation completed and summarized in h 10.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10655973
• MDR Text Key: 210625651
• Report Number: 3012307300-2020-10257
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 1 YR