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

Catalog Number C45101340-NLJ

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)

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

Event Date 09/18/2019

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# 617147.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected with a 12? distance according to procedure with normal conditions of illumination.During the visual inspection, it was found that the tube is deformed.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.During the verification, 32 assemblies were visually reviewed; no units were detected with damages or contaminations.All the verifications are being performed by the production personnel and verified by quality inspectors.During all the assembly process, the parts are being inspected for any damaged or contamination by the operator.The root cause of the reported issue was that the production personnel did not detect the deformed tube during processing.Actions were taken to mitigate the reported issue: a quality alert (qalert) was generated to ensure that operators can detect any deformed or damaged tube and the product personnel were trained on the qalert process.

Event Description

It was reported that upon opening the package the customer noticed that the anesthesia circuit was deformed during a pre-use check.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; west 13-4 chuoh-ku, sapporo; minneapolis, MN 55442
• MDR Report Key: 15656227
• MDR Text Key: 303617449
• Report Number: 3012307300-2022-25878
• 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 Catalogue Number: C45101340-NLJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• 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