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

Model Number 101/860/080

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

Other, 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 Description

It was reported that the pilot balloon had fallen out during patient use.Adverse patient effects are unknown.

Manufacturer Narrative

Other text: g2 email is: regulatory.Responses@icumed.Com.Device evaluation: one device was returned for investigation.Under visual inspection we noticed that inflation line was detached from pilot balloon as reported by customer.This was determined to be caused by a supplied item fault.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: PORTEX TUBES BLUSELECT
• Type of Device: 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: 18144422
• MDR Text Key: 328205439
• Report Number: 3012307300-2023-10522
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1