MAUDE Adverse Event Report: SMITHS MEDICAL BIVONA NEONATAL TRACH TUBE

Model Number 358040

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Information (3190)

Event Date 05/01/2014

Event Type  Injury  

Event Description

An 8 french in-line suction catheter could not be separated from the 4.0 neo cts smiths medical cuffed trach tube that was in the child.Mom tried using the wedge to separate the two items with no success.Child had to be extubated and a new trach tube was inserted due to catheter being stuck on trach hub.Upon further inspection of the trach tube, the design of the trach tube hub is a type that was used at bivona years ago.The design was known to create a problem when attempting to remove any adapter from the hub.

• Brand Name: BIVONA NEONATAL TRACH TUBE
• Type of Device: TRACH TUBE
• Manufacturer (Section D): SMITHS MEDICAL; st. paul 55112
• MDR Report Key: 3842925
• MDR Text Key: 4411992
• Report Number: MW5036374
• Device Sequence Number: 1
• Product Code: BTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 358040
• Device Catalogue Number: 358040
• Device Lot Number: 2527213
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR