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

Model Number	101/860/070
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inflation was removed when the tracheostomy tube was replaced.It was not torn.Adverse patient effects are unknown.
Additional Manufacturer Narrative
Other text: b3: month and year of event have been provided, day is unknown.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: h3, h6 - updated.One device was returned for evaluation.Under visual inspection it was noted that the inflation line was detached from the pilot balloon.The reported complaint is confirmed.The root cause could not be determined.This issue will continue to be monitored and further actions taken accordingly.A review of the device of the device history records could not be completed as no lot number was provided by the customer.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• 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: 17591782
• Report Number: 3012307300-2023-08227
• Device Sequence Number: 6263378
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• 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): 09/06/2023

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: 101/860/070
• Device Catalogue Number: 101/860/070CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/08/2023
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/06/2023
• 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