MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO

Catalog Number 60SP030 

Device Problems Break (1069); Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

Event Type  Injury  

Event Description

Information was received that a smiths medical bivona uncuffed neonatal and pediatric tracheostomy tube.No adverse patient effects were reported.

Manufacturer Narrative

Three pictures were received for review.In picture 1, one tube is observed in used, connector is being covered by a cap.In picture 2, it is observed that tube has a split in the silicon and in picture 3, the original box is noted.Two bivona tracheostomy tubes were returned for analysis in used condition.Upon visual inspection a split in the silicon was observed in both samples and in the same location.The manufacturing process and assembly processes were both reviewed and deemed adequate.The training was found to be up to date.Verification of 32 assemblies were reviewed to see if they had molding issues; no damage was found.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10064239
• MDR Text Key: 191241449
• Report Number: 3012307300-2020-04174
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2020
• Device Catalogue Number: 60SP030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 07/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR