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

Catalog Number C45101340-NLJ

Device Problem Material Deformation (2976)

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

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown.No information provided to date.Premarket (510k) number is unknown.This mdr was generated under protocol b10009704, as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected at a distance of 12? to 24? under normal conditions of illumination.The samples have the tube not completely collapsed.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.Visual inspection: prior to packaging, a random sample of 32 units was taken from the manufacturing process, the units were visually inspected, in order to verify that the tube is completely collapsed.No discrepancies were found.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.The most probable root cause of the reported issue was that the production personnel did not detect the tube not completely collapsed.Actions were taken to mitigate the reported issue: a quality alert (qalert) was generated to ensure that operators can detect any tube that is not completely collapsed.Production personnel was trained on the qalert.

Event Description

It was reported that upon opening the package, the customer noticed the anesthesia circuit was already stretched.No patient injury was reported.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• 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; 1, 3-10-15 hakata station east; minneapolis, MN 55442
• MDR Report Key: 15656234
• MDR Text Key: 306608703
• Report Number: 3012307300-2022-25883
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 3858511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1