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

Catalog Number C1032J

Device Problem Gas/Air Leak (2946)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Udi and pma/510k is unknown, no product information has been provided to date.Expiration date and manufacture date are unknown, no information is available based on reported lot number.Month and year of event have been provided ,day is unknown.Five pictures and one sample device were received for investigation.The provided photos demonstrate a torn section on the circuit tubing of the reported device.The reported issue was confirmed in the provided sample device during both visual inspection and functional testing, which identified leakage from a tear in the circuit tubing.No lot number was reported, therefore a review of manufacturing device history records could not be conducted.However the investigation attributed the root cause of this issue to an injection molding fault during the manufacturing process.This issue will continue to be monitored and further actions taken accordingly.

Event Description

It was reported that an air leak alarm went off during the pre-use check.No patient involvement or injury was reported.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16591172
• MDR Text Key: 311788360
• Report Number: 3012307300-2023-02897
• 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
• Report Date: 03/22/2023

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: C1032J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 03/22/2023
• 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