MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C37101307J

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the product was observed.No patient involvement.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two (2) product samples and three (3) photos were received for evaluation.Visual and functional testing were performed.Visual inspection of the photos found a connector with a crack on the edge.Visual inspection of the samples found a crack was detected on one connector from one sample, in the other no discrepancies were detected; crack is on external diameter around of the fluid path.Functional testing found both circuits successfully past the leak tests; thus failure mode is not confirmed.No problem found.Root cause cannot be determined as the samples were successfully tested.Device expiration date (d4) and device manufacture date (h4) updated.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 14220031
• MDR Text Key: 290173068
• Report Number: 3012307300-2022-06984
• Device Sequence Number: 1
• Product Code: CAI
• 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,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101307J
• Device Lot Number: 4206602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1