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

Catalog Number C45101344-NLJ

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown.No information provided to date.Premarket (510k) number is unknown.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A corrective and preventative action has been opened to address the reported issue.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 at a distance of 12? under normal lighting to received unit, in order to detect any damage on the unit.No discrepancies detected.The breathing bag did not pass the leak test.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.After the leak test, visual inspection was performed on the same samples to verify any damage on the components.A random sample of 32 units was taken from the manufacturing process, in order to perform a visual inspection to verify that all components were free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts or other workmanship defects that can affect assembly function or appearance.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.The root cause of the reported issue was unable to be determined.Actions were taken to mitigate the reported issue: a corrective and preventative action has been opened to address the reported issue in order to determine the root cause and implement proper corrective actions.

Event Description

It was reported that the customer performed a pre-use air leak testing of the product using an anesthesia device and noticed the product could not pass it.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; motohakma, naka-ku, yokohama; minneapolis, MN 55442
• MDR Report Key: 15656229
• MDR Text Key: 306918715
• Report Number: 3012307300-2022-25881
• 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: C45101344-NLJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• 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