MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/870/070

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2020

Event Type  Injury  

Event Description

Information was received indicating that the flange to a smiths medical portex blue line ultra tracheostomy tube was observed to be damaged following 8 days of use.There were no reported adverse patient effects.

Manufacturer Narrative

Other, other text: h2: additional information received 07/02/2020: see b5 and h1 h3: device evaluation: completed 07/10/2020: one portex tube blue line classic tracheostomy tube from p/n (b)(4) l/n unknown was received in used condition without its original packaging.The sample was visually inspected, at a distance of 12" to 16" and normal conditions of illumination; the connector was found damaged.Relevant documents were reviewed and considered adequate and correct for testing and inspection activities.The most probable cause of the issue is that the product became damaged after it left the smiths medical facility.

Event Description

Additional information was received indicating that a tube change out was performed.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10171404
• MDR Text Key: 195702016
• Report Number: 3012307300-2020-06069
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315038785
• UDI-Public: 15019315038785
• Combination Product (y/n): N
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/870/070
• Device Catalogue Number: 100/870/070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention