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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that immediately after opening and testing using an anesthetic machine there was a leak.No patient injury or clinical affects was reported.

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided, day is unknown.D4: udi number 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.

Manufacturer Narrative

Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.Photos received: seven (7) photos were included for evaluation; photos show the leaking in the component.Returned samples were received without the original package.Per visual inspection, it was not possible to detect any issue in the circuit and assembly.Per functional leak testing, the result of the circuit tube test was rejected because there was an air leak.The complaint was confirmed.Other analysis, the manufacturing 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.Based on the analysis conducted in the sample provided, the circuit assembly presents leakage, a 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 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: 18058243
• MDR Text Key: 327213167
• Report Number: 3012307300-2023-10182
• 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

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C49101320J
• Device Lot Number: 4354032
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1