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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Respiratory Distress (2045)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received that clamp that secures the tube on a smiths medical portex adjustable flange tracheostomy tube was not holding and loosened.Patient was in distress.Unplanned tracheostomy performed.No adverse patient effects were reported.

• Brand Name: PORTEX ADJUSTABLE FLANGE 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 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9685107
• MDR Text Key: 178325045
• Report Number: 3012307300-2020-00956
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 87