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

Catalog Number CA1300/4P5/000JP

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: d4: expiration date, udi number and h4: manufacture date are not available.Based on the reported lot number.G5: 510k is blank, device is exempt.One device was received in its original package.Per visual inspection, the components revealed a pinhole (or tear) in the breathing bag.Per functional testing, leakage from the breathing bag was observed.No other anomaly was observed.The complaint was confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The device has been sent to a secondary investigation site for further investigation including root cause.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 during a pre-use check, air leaked from the anesthesia bag.No patient injury or clinical affects was reported.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.Email is: (b)(6).Three photos and one device sample were received without the original package.Per visual inspection, it was possible to detect a tear in the breathing bag.The result of breathing bag test was rejected because there was air leak.The complaint was confirmed.Based on the analysis conducted in the sample provided, a root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The issue has been escalated to the supplier for further consideration and root cause analysis.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• 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: 18187746
• MDR Text Key: 328771334
• Report Number: 3012307300-2023-10693
• 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: 02/20/2024

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: CA1300/4P5/000JP
• Device Lot Number: 230824
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/20/2024
• 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