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

Catalog Number C45091342-NLJ

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4: udi section is unknown, no information has been provided to date.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 while in use with a patient, the device was leaking.Adverse effects are unknown.

Manufacturer Narrative

Other text: g1,2 email is: regulatory.Responses@icumed.Com.Two (2) photos were included for evaluation; photos show the damage in the filter.One device was received without the original package.Per visual inspection, it was not possible to detect the damage in the assembly filter.Per functional leak testing, the result of the circuit tube test was rejected because there was air leak.The complaint was confirmed.Other analysis, the process was reviewed to try to identify somewhere that could result in the damage presented in the part returned, nothing was found on the workstation that could damage the connector during the review.The root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.While a root cause was unable to be determined, the reported issue has been escalated and is currently being reviewed.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT, EXPANDABLE
• 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: 18032401
• MDR Text Key: 326875931
• Report Number: 3012307300-2023-10040
• 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: 12/21/2023

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: C45091342-NLJ
• Device Lot Number: 4347795
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1