MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX THERMOVENT T - HEAT AND MOISTURE EXCHANGER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Catalog Number 100/570JCZ

Device Problem Environmental Particulates (2930)

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

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.Protocol #: premarket (510k) number is unknown.One unused unopened unit was received for investigation.Under visual inspection it was noticed that there are two small particles inside unit pack.Based on shape and color particles were evaluated to be residue of cardboard core (paper is supplied to be winded on such core) and small piece of corrugated paper.Both particles were found to be falling into size interval 0.08 - 0.2mm2 where there are allowed three particles with this size.Based on above measurement the evaluated returned product is found to be conforming.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.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that before opening the package, the customer found a dust-like substance in it.No patient injury reported.

• Brand Name: PORTEX THERMOVENT T - HEAT AND MOISTURE EXCHANGER
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• 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; 2-3-2 kamiochiai,; minneapolis, MN 55442
• MDR Report Key: 15362174
• MDR Text Key: 305802808
• Report Number: 3012307300-2022-17906
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2022

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: Other
• Device Catalogue Number: 100/570JCZ
• Device Lot Number: 3883164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1