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

Model Number 101/870/070CZ

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that during the use of the product, the pilot balloon got detached from the inflation line, and the cuff was found deflated.No patient injury reported.The reported lot number couldn't be verified.

Manufacturer Narrative

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.

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The inflation line was detached from the pilot balloon and the complaint is confirmed.A dhr (device history review) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No manufacturing or service issues were identified as causes of the customer's reported problem during the review of the service and repair records.

• 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16129857
• MDR Text Key: 306981502
• Report Number: 3012307300-2023-00299
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076202
• UDI-Public: 15019517076202
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 101/870/070CZ
• Device Catalogue Number: 101/870/070CZ
• Device Lot Number: 4065614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening