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

Catalog Number C45101314J

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4: udi section is unknown.G5: 510k is blank, device is exempt.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 upon opening, the circuit was found damaged.Patient involvement is unknown.

Manufacturer Narrative

Other text: h3 and h6 - updated.One device and two photos were returned for investigation.Both photos showed damage to the tune.Visual inspection of the returned device detected damage on the corrugated tube, which causes an air leak.A functional test was also conducted and the result is that the corrugated tube was not acceptable.The complaint is confirmed.Based on the analysis conducted on the sample provided, this failure mode has been caused due to damage or wear in the corrugation forming block.All mitigations on place were verified and confirmed that it has been executed according, it will be continue monitoring this failure condition in this product for threshold or escalation.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX ANESTHESIA EXPANDABLE 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: 17443474
• MDR Text Key: 320239934
• Report Number: 3012307300-2023-07713
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101314J
• Device Lot Number: 4361671
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1