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

Model Number 101/870/075

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2023

Event Type  malfunction  

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.

Event Description

It was reported that the pilot balloon was replaced in the morning, and in the afternoon of the same day.It was discovered that the pilot balloon had fallen off, and use was discontinued.Adverse patient effects are unknown.

Manufacturer Narrative

Device evaluation: one device was returned for investigation.Under visual inspection the inflation line was found detached from the pilot balloon as reported by customer.The complaint was confirmed.This was listed as a supplied item fault.This issue will continue to be monitored and further actions taken accordingly.No lot number was provided therefore no device history report (dhr) review could be completed.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• 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: 17813725
• MDR Text Key: 324236014
• Report Number: 3012307300-2023-09225
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076219
• UDI-Public: 15019517076219
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/870/075
• Device Catalogue Number: 101/870/075CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• 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