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

Catalog Number C1034J

Device Problem Gas/Air Leak (2946)

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

Event Date 05/01/2022

Event Type  malfunction  

Event Description

It was reported that during pre-use check of the device, leakage of air was observed from the product.The customer further checked it and found a crack in the corrugated tube.No additional information was available.No patient was involved.

Manufacturer Narrative

The device was returned, and the sample present a tier damage (hole) in the circuit.The circuit was connected and failed the leak test.The failure reported could not be reproduced using the tools from molding and assembly process.(updated h6) review of the device history record showed no issues related to the reported defect.The damage is believed to have occurred after the product left the manufacturing facility.

• Brand Name: PORTEX ANESTHESIA BREATHING 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14700573
• MDR Text Key: 295890539
• Report Number: 3012307300-2022-11981
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C1034J
• Device Lot Number: 4222992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1