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

Model Number C37101308J

Device Problem Crack (1135)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, a crack was found in the corrugated tube.No patient injury was reported.

Manufacturer Narrative

Device evaluation a sample and pictures were received to perform an investigation.A visual inspection of the returned sample found the presence of a hole in the breathing circuit.Functional testing was performed using a leak test and it confirmed that the returned sample had a leak.Current tools of the assembly process were used to replicate the reported problem and the failure reported was unable to be reproduced.It was determined that the root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from the molding and assembly process.The damage (hole) was determined to occur after the manufacturing process.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: PORTEX
• 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: 13590625
• MDR Text Key: 286050305
• Report Number: 3012307300-2022-04077
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C37101308J
• Device Catalogue Number: C37101308J
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1