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

Patient identifier: one patient, two product malfunctions.(b)(6).Both represent the same patient.This is the second malfunction report for the related complaints.First malfunction reported under manufacturing report number 3012307300-2023-02653.Date of event: month and year of event have been provided, day is unknown.Lot number, expiration date and: device manufacture date are 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 replacing a failed trach tube, the customer experienced another fault.The tube allowed ventilation to be performed properly; however the fiberscope would not pass through it.No patient injury was reported.It was not reported how the situation was resolved.

Manufacturer Narrative

Two (2) devices were received in used condition without original package.Both devices were visually inspected.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.

• 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: 16559207
• MDR Text Key: 311665442
• Report Number: 3012307300-2023-02662
• 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
• Report Date: 10/20/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2023
• 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