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

Catalog Number C37101329-NLJ.

Device Problem Leak/Splash (1354)

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

Event Date 11/01/2018

Event Type  malfunction  

Event Description

It was reported that during the pre-use check the product had air leak.No patient injury was reported.

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.Protocol number, 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.A product sample was received for evaluation.Visual and functional testing were performed.One sample was received in used conditions without its original packaging.The sample was visually inspected with a 12 inches distance under normal conditions of illumination.During the visual inspection, no discrepancies were detected.During the functional testing the sample did not pass the leak test.The root cause was related to the manufacturing process.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.A corrective and preventative action has been opened to address the reported issue.

• Brand Name: PORTEX GENERAL ANESTHESIA BAGS
• 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; minneapolis, MN 55442
• MDR Report Key: 15665661
• MDR Text Key: 306788677
• Report Number: 3012307300-2022-26106
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2022

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: Health Professional
• Device Expiration Date: 08/14/2021
• Device Catalogue Number: C37101329-NLJ.
• Device Lot Number: 3687375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1