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

Catalog Number 100/570/015

Device Problem Material Discolored (1170)

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

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).(udi) is unknown.No product information has been provided to date.510k is unknown.No information has been provided to date.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.One not opened unit pack was received in plastic bag for investigation.Under visual inspection unit packaging seems to be within specification - reported yellow shade was visible when the unit pack was compared with recent production.Furthermore we noticed that paper element of filter is degraded.Due to fact that all levels of packaging (shelf carton and unit pack) and paper element of product itself changed color and degraded it is the most probable that product was exposed to uncontrolled environmental conditions out of the distribution system because there were no similar customer complaints identified.Unfortunately the root cause cannot be identified.No further action will be taken as no trend of confirmed complaints in relation with this issue have been identified.

Event Description

It was reported that the product while on the shelf turned yellowish is color.No patient injury was reported.

• Brand Name: PORTEX THERMOVENT HME SYSTEMS
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; jianguo n. road; minneapolis, MN 55442
• MDR Report Key: 15674632
• MDR Text Key: 306980467
• Report Number: 3012307300-2022-26268
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 100/570/015
• Device Lot Number: 2664622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1