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

Catalog Number 100/506/030

Device Problem Obstruction of Flow (2423)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

One patient, two product malfunctions.(b)(6) and (b)(6) both represent the same patient.This is the first malfunction report for the related complaints.Month and year of event have been provided, day is unknown.Lot number, expiration date and device manufacture date is unknown, no product 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 after intubating the product into the patient, it was confirmed the fiberscope passed through it, but air ventilation was unable to be performed.So they removed the product and inserted it again.After that, ventilation was made possible.The customer then changed the product to another new one (a second device) and it allowed ventilation to be performed properly; however the fiberscope would not pass through the second device.No patient injury was reported.

Manufacturer Narrative

Two (2) devices were received in used condition without original package.Both devices were visually inspected at a distance of 12 to 16 inches under normal conditions of illumination; no visual conditions were detected in both devices.An occlusion test was performed to verify that the inner diameter of the tube was free; both devices passed.The complaint could not be confirmed.A device history record (dhr) review could not be performed as the lot number is unknown.No corrective actions taken since the complaint was not confirmed.

Manufacturer Narrative

Other text: h6.Health impact; updated.

• Brand Name: PORTEX BLUE LINE TRACHEOSTOMY TUBES
• 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; 7-1-1 akasaka; minneapolis, MN 55442
• MDR Report Key: 16556871
• MDR Text Key: 311674800
• Report Number: 3012307300-2023-02653
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030381
• 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,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/506/030
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• 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