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

Model Number	101/815/060
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: d4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the external inflation cuff had came off twice.There was patient involvement but there was no injury.
Event or Problem Description
Additional information received.The lot number remains unknown after attempts with supply company.
Additional Manufacturer Narrative
Describe event or problem, 10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Email is: (b)(6) one device sample was received in used condition without original package.Per visual inspection, the pilot balloon is detached from the inflation line.The complaint was confirmed, and no other analysis was performed.The root cause is attributed to manufacturing.A device history record (dhr) review could not be performed as the lot number was unknown.The issue has been escalated to address root cause investigation for detaching pilot balloon from inflation line tube.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17368453
• Report Number: 3012307300-2023-07488
• Device Sequence Number: 19802228
• Product Code: BTO
• UDI-Device Identifier: 15019517077339
• UDI-Public: 15019517077339
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: 101/815/060
• Device Catalogue Number: 101/815/060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/27/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown