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

Catalog Number CA24E0/4P6/000JP

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided; day is unknown.D4: expiration date and h4: manufacture date is unknown; no information is available based on reported lot number.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.

Event Description

It was reported there was leakage.Patient involvement unknown.

Manufacturer Narrative

Other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Visual inspection confirmed a tear in the breathing circuit.No other anomaly was found.A leak test was performed, and leakage from it was observed confirming the complaint.It was unknown what caused the tear or leak however, it was considered that the leakage occurred before being received by the supplier.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The device was forwarded to the manufacturing site for further device analysis.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.Secondary component investigation: one device sample was received without its original package.Three photos were included for evaluation; photos showed damage tube in the complaint sample.Per visual inspection, it was possible to detect damage on the corrugated tube, which caused air leaking.The root cause was manufacturing due to damage or wear in the corrugation forming block.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Review blockchain and identify damaged or wear blocks to repair and avoid repeat failure mode.All mitigations in place were verified and it was confirmed has been executed accordingly, the manufacturer will monitor this failure condition in this product for threshold or escalation.

• 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: 17368451
• MDR Text Key: 319678421
• Report Number: 3012307300-2023-07484
• 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,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA24E0/4P6/000JP
• Device Lot Number: 230328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• 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