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

Catalog Number FU15IN45NSA329N

Device Problem Difficult to Insert (1316)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

It was reported that the customer has two trach tubes that the current suction catheter will not go through.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.Additional information was requested; however, no further information was received.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and 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.Udi number and pma/510k are unknown, no product information has been provided to date.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Functional test was performed; using the 12fr catheter provided by the complainant, it was inserted into the ids of the returned devices.The catheter was able to be inserted, but it did not easily slide through the id.The id of the devices were checked at both ends of the device using pin and a cross-sectional sample was taken from the distal tip of both devices.The ids from the cross-sectional samples were measured using a comparator: sample 1 (id 4.38mm od 6.74 mm) and sample 2 (id 4.37 mm od 6.75 mm).The ids measured on the low end of the manufacturing specification of 4.5 millimeter but were determined to meet the manufacturing specification for a 4.5 device.The investigation did not identify any manufacturing defect.No fault was found with the device.No corrective actions were needed.The manufacturer regularly analyzes complaint data and trends and will take further actions accordingly if needed.The root cause of the reported problem was unknown/undetermined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEAL (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: 15463087
• MDR Text Key: 306171068
• Report Number: 3012307300-2022-20068
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: FU15IN45NSA329N
• Device Lot Number: GA032103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1