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

Catalog Number CA1700/000/000JP

Device Problem Gas/Air Leak (2946)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported that the during the pre-use check, leakage of air from the product was observed.No patient injury or clinical affects was reported.

Manufacturer Narrative

Month and year of event have been provided, day is unknown.Lot number, expiration date and udi number.Device manufacture date is unknown.No product information has been provided to date.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

One device was received.As a result of visually observing the device, a crack on the connector was found.A leak test was conducted, and the complaint was confirmed as the circuit tube was leaking due elbow damage.Based on the analysis conducted in the sample provided, the root cause could be due to the improper use of the product.A device history record (dhr) review could not be performed as the lot number was unknown.No action taken, this failure condition will be monitored 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: 16621243
• MDR Text Key: 312073447
• Report Number: 3012307300-2023-03035
• 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: 07/11/2023

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: CA1700/000/000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1