MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL BIVONA TUBES NEO/PED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problems Infusion or Flow Problem (2964); Incomplete or Inadequate Connection (4037)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received that 90-95 percent of the time when checking the inflation of patient's smiths medical tracheostomy, it does not inflate all the way around.Customer reports concern for proper ventilation.No further information provided, and no patient adverse effects reported.

• Brand Name: SMITHS MEDICAL BIVONA TUBES NEO/PED
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8794584
• MDR Text Key: 151174952
• Report Number: 3012307300-2019-03538
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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