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

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Per the voicemail notification: the custom trach was defective.No adverse patient effects were reported.No further information as of now.

• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR), PRODUCT CODE: BTO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8974878
• MDR Text Key: 156908950
• Report Number: 3012307300-2019-04407
• 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: consumer
• Type of Report: Initial
• Report Date: 09/08/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1