MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE

Catalog Number HT14GS40NSA240S

Device Problems Fracture (1260); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results.

Event Description

A report was received stating the listed tracheostomy tube was placed in a patient on (b)(6) 2015; on (b)(6) 2015 the nurse reported difficulties suctioning the tracheostomy tube due to resistance felt with the suctioning device.The tracheostomy tube was removed and emergently replaced with a new one.Inspection of the removed device revealed a crack in the tracheostomy tube material.No patient injury was reported.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary, IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary, IN 46406
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5324683
• MDR Text Key: 34285807
• Report Number: 2183502-2015-00993
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: HT14GS40NSA240S
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2015
• 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: Initial
• Patient Sequence Number: 1