MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 100/594/000

Device Problem Mechanical Problem (1384)

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

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown; no additional information was received.No lot number was provided; therefore, device history record (dhr) review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.The returned sample was found rejected, since the edge of the product did not reach the limits after applying 3.5 kg force.The complaint was confirmed.The root cause of the reported issue was found to be related to a supplier issue since the defective component provided by the supplier.

Event Description

It was reported that during the use of the product, the customer noticed the anesthesia circuit-side connector did not fit well with a mating one and was unable to be connected to it.No patient injury was reported.

• Brand Name: PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• 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; 4-1-5, izumi-chuo, izumi-ku; minneapolis, MN 55442
• MDR Report Key: 15443259
• MDR Text Key: 306157700
• Report Number: 3012307300-2022-19559
• Device Sequence Number: 1
• Product Code: BZA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 100/594/000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• 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