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

Catalog Number 670003

Device Problems Leak/Splash (1354); Component Missing (2306)

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

Event Date 10/01/2019

Event Type  malfunction  

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.510k is unknown.No information has been provided to date.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.One sample was received in used conditions without its original packaging.The sample was visually inspected with a 12 to 24 inches distance under normal conditions of illumination.During the visual inspection, the sample did not have the white tape.The most probable root cause was production personnel did not detect the missing tape on the breathing bag, as preventive action an update to the visual aid was created to configure the job layout to help the operators in the performance of this operation.

Event Description

It was reported that during a pre-use check, the customer noticed the adhesive tape was not attached to the base of the connector, where leakage of air was found.No patient injury was reported.

• 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; 1, 3-10-15 hakata station east; minneapolis, MN 55442
• MDR Report Key: 15665566
• MDR Text Key: 306701722
• Report Number: 3012307300-2022-26105
• 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 Catalogue Number: 670003
• 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
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• 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