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

Model Number	101/810/080
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a crack occurred while cleaning the inner tube.The customer reported that this was the first time that such an event has happened.Adverse patient effects are unknown.
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.
Additional Manufacturer Narrative
Other text: h6 codes updated.Device evaluation: one device was returned for investigation in used conditions.Visual inspection confirmed the customer complaint of the inner cannula being cracked.The inner cannula wall thickness was then measured and met all specifications which ruled out thin inner walls as the cause of the crack.The most probable root cause of the crack is due to excessive force used while cleaning or reprocessing of the device.No lot number was provided, no device history review done.

• 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: 17433341
• Report Number: 3012307300-2023-07635
• Device Sequence Number: 6834673
• Product Code: BTO
• UDI-Device Identifier: 15019517076301
• UDI-Public: 15019517076301
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: 101/810/080
• Device Catalogue Number: 101/810/080CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/12/2023
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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