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

Catalog Number CA24E0/4K2/004JP

Device Problem Connection Problem (2900)

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

Event Date 01/19/2021

Event Type  malfunction  

Event Description

It was reported that the connection between the product and anesthesia was not attached.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Unit returned was received inside of a plastic bag which is not the original package.Sample can't be submitted for leak test inspection because the connectors are necessary to fit in the leak tester equipment.Additionally, process assembly inspect the pieces at 100%, they can detect if the product is without connector.Failure reported could not be reproduced on the process.The root cause cannot be confirmed, the most probable root cause occurred after the product left the manufacturing facilities and the sample returned was already open it by the customer.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.No problems or issues were identified during this device history record review.D5: operator of device is unknown.G5: premarket (510k) number is unknown.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16852204
• MDR Text Key: 314356210
• Report Number: 3012307300-2023-04859
• 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
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CA24E0/4K2/004JP
• Device Lot Number: 201008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1