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

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 returned.Visual inspection confirmed a dent in the breathing circuit.No other anomaly was found.A leak test was performed, and no leakage was observed.The observed dent did not affect the function of the device.The complaint could not be confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

Manufacturer Narrative

Email is: regulatory.(b)(6).Three photos and one device sample were received without the original package.Per visual inspection, it was possible to detect damage on the corrugated tube, which caused air leaking.A leak test was performed in which the results were not acceptable.The complaint was confirmed.Based on the analysis conducted in the sample provided, the failure could be caused due to improper handling of the product outside of the manufacturing facilities by the end user.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken as the root cause could not be traced to manufacturing.

• 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: 17368448
• MDR Text Key: 319958447
• Report Number: 3012307300-2023-07483
• 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

• 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: 230426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 07/31/2023; 08/20/2023
• Supplement Dates FDA Received: 08/01/2023; 02/26/2024
• 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