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

Catalog Number C1034J

Device Problem Obstruction of Flow (2423)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number, udi section expiration date and manufacture date are unknown, no information has been provided to date.Device is exempt.Month and year of event have been provided, day is unknown.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during the pre-use check, the breathing circuit was found occluded.No patient injury reported.

Manufacturer Narrative

Device evaluation: five photos and one device were received for investigation.The photos demonstrated crimping on the distal end of the inner blue tubing of the device, visibly reducing its inner diameter.Visual inspection of the sample device identified the same crimping on the inner blue tubing.The sample's tubing was cut to observe a cross section of the crimped area, and the inner diameter of the tubing was determined to have been reduced by the crimping, resulting in a partial occlusion, confirming the reported complaint.Based on the analysis on the returned unit and the mitigations during the manufacturing process, the condition cannot be attributed to the manufacturing process and the root cause is as supplier provided component with defect.A review of the manufacturing device history records for the reported lot numbers found no nonconformances that could have resulted in the observed issue.Manufacturing personnel have been informed of the complaint details, and complaint trends will be monitored and further action taken as required.

• 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: 16587502
• MDR Text Key: 311748461
• Report Number: 3012307300-2023-02849
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C1034J
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2023
• 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