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

Catalog Number CA25B0/400/000JP

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

Month and year of event have been provided, day is unknown.D4: udi section, expirtation date and h4: manufacture date are not available based on the reported lot number.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 there was an air leak."air leaks were found in 4 of the 10 bottles in a box".Patient involvement is unknown.

Manufacturer Narrative

G1,2 email is: email is: regulatory.Responses@icumed.Com.Eight kits were received.Per visual inspection, no anomalies were observed.Per functional testing, leakage from 2 breathing circuits was confirmed.The affected circuits were sent to another manufacturing facility for further device analysis.A secondary visual inspection detected embedded resin in the corrugated tube.Secondary functional testing confirmed air leaks.The complaint was confirmed.The root cause was from manufacturing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue has been escalated.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT, CORRUGATED
• 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: 17939384
• MDR Text Key: 326395635
• Report Number: 3012307300-2023-09682
• 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: CA25B0/400/000JP
• Device Lot Number: 230705
• 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: 09/19/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1