MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND PEDIATRIC/ NEONATAL TRACHEOSTROMY; 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 burst later that day.There was nothing remarkable about the patient anatomy to cause this.Patient had easy removals and insertions and had been using bivona for at least 6 months without issue.There were no reported adverse events.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.Visual and functional testing were performed.Two samples were received without lot number provided in used conditions, with their original lid and with its certificate of decontamination.During the functional testing, leaks were found in the cuff.It was observed the cuff surface was worn with areas with stretch marks.Holes were present in the worn areas.The complaint was confirmed.The most probable root cause is that damaged occurred after the product left the medical facility.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: BIVONA FLEXTEND PEDIATRIC/ NEONATAL TRACHEOSTROMY
• 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: 11873594
• MDR Text Key: 252298555
• Report Number: 3012307300-2021-04928
• 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
• Report Date: 04/08/2023

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
• 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