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

Catalog Number C49101320J

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that there was a leak in the circuit.Patient involvement is unknown.

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.D4: lot number, expiration date, udi section and h4: manufacture date are unknown, no information has been provided to date.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.

Manufacturer Narrative

Evaluation codes: updated device evaluation: one device was returned for investigation.Visual inspection was not able to detect damage.Functional testing found the corrugated tubing assembly test was not acceptable because there was air leak; complaint was confirmed.Possible root cause was attributed to the inappropriate handling of the product.A review of the device history record (dhr) review could not be completed as not lot number was provided.No action will be taken because the component was damaged due to improper handling by the end user.

• Brand Name: PORTEX EXPANDABLE 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: 17745522
• MDR Text Key: 323401477
• Report Number: 3012307300-2023-08917
• 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: 10/26/2023

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: C49101320J
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/26/2023
• 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